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Mectacer Biolox Delta Femoral Ball Head

Model 01.29.208 · Medacta International SA · DI 07630030809194

LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented · Class II · 21 CFR 888.3353

UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (141)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

Injury: 141

358102019-01: 2 reports for this device; peer average 2.72/device2019-02: 0 reports for this device; peer average 2.45/device2019-03: 1 reports for this device; peer average 2.79/device2019-04: 2 reports for this device; peer average 2.65/device2019-05: 1 reports for this device; peer average 2.07/device2019-06: 1 reports for this device; peer average 1.85/device2019-07: 2 reports for this device; peer average 1.73/device2019-08: 1 reports for this device; peer average 2.19/device2019-09: 1 reports for this device; peer average 2.2/device2019-10: 0 reports for this device; peer average 2.5/device2019-11: 0 reports for this device; peer average 2.2/device2019-12: 0 reports for this device; peer average 2.55/device2020-01: 1 reports for this device; peer average 3.08/device2020-02: 0 reports for this device; peer average 2.52/device2020-03: 0 reports for this device; peer average 3.17/device2020-04: 2 reports for this device; peer average 2.37/device2020-05: 0 reports for this device; peer average 2.26/device2020-06: 0 reports for this device; peer average 2.13/device2020-07: 0 reports for this device; peer average 2.62/device2020-08: 0 reports for this device; peer average 2.21/device2020-09: 0 reports for this device; peer average 2.8/device2020-10: 0 reports for this device; peer average 2.76/device2020-11: 4 reports for this device; peer average 2.4/device2020-12: 2 reports for this device; peer average 2.47/device2021-01: 0 reports for this device; peer average 2.52/device2021-02: 2 reports for this device; peer average 2.24/device2021-03: 0 reports for this device; peer average 2.2/device2021-04: 0 reports for this device; peer average 2.17/device2021-05: 2 reports for this device; peer average 2.19/device2021-06: 0 reports for this device; peer average 2.49/device2021-07: 0 reports for this device; peer average 2.58/device2021-08: 0 reports for this device; peer average 2.56/device2021-09: 0 reports for this device; peer average 2.75/device2021-10: 0 reports for this device; peer average 2.46/device2021-11: 0 reports for this device; peer average 2.22/device2021-12: 0 reports for this device; peer average 2.46/device2022-01: 0 reports for this device; peer average 2.31/device2022-02: 0 reports for this device; peer average 2.33/device2022-03: 0 reports for this device; peer average 2.38/device2022-04: 0 reports for this device; peer average 2.3/device2022-05: 0 reports for this device; peer average 2.46/device2022-06: 0 reports for this device; peer average 2.32/device2022-07: 0 reports for this device; peer average 2.32/device2022-08: 2 reports for this device; peer average 2.33/device2022-09: 0 reports for this device; peer average 2.44/device2022-10: 0 reports for this device; peer average 2.4/device2022-11: 0 reports for this device; peer average 2.48/device2022-12: 0 reports for this device; peer average 2.48/device2023-01: 0 reports for this device; peer average 2.63/device2023-02: 0 reports for this device; peer average 2.34/device2023-03: 0 reports for this device; peer average 2.47/device2023-04: 4 reports for this device; peer average 2.44/device2023-05: 0 reports for this device; peer average 2.35/device2023-06: 6 reports for this device; peer average 2.45/device2023-07: 1 reports for this device; peer average 2.31/device2023-08: 1 reports for this device; peer average 2.02/device2023-09: 3 reports for this device; peer average 2.04/device2023-10: 3 reports for this device; peer average 1.8/device2023-11: 2 reports for this device; peer average 1.78/device2023-12: 2 reports for this device; peer average 1.89/device2024-01: 1 reports for this device; peer average 1.84/device2024-02: 0 reports for this device; peer average 2.21/device2024-03: 1 reports for this device; peer average 2.01/device2024-04: 1 reports for this device; peer average 1.91/device2024-05: 1 reports for this device; peer average 2.24/device2024-06: 2 reports for this device; peer average 2/device2024-07: 1 reports for this device; peer average 1.82/device2024-08: 1 reports for this device; peer average 2.05/device2024-09: 4 reports for this device; peer average 2.05/device2024-10: 4 reports for this device; peer average 1.87/device2024-11: 4 reports for this device; peer average 1.99/device2024-12: 2 reports for this device; peer average 1.71/device2025-01: 6 reports for this device; peer average 2.18/device2025-02: 5 reports for this device; peer average 1.66/device2025-03: 2 reports for this device; peer average 1.85/device2025-04: 0 reports for this device; peer average 1.95/device2025-05: 4 reports for this device; peer average 1.94/device2025-06: 3 reports for this device; peer average 1.97/device2025-07: 6 reports for this device; peer average 1.92/device2025-08: 2 reports for this device; peer average 1.94/device2025-09: 3 reports for this device; peer average 1.75/device2025-10: 0 reports for this device; peer average 1.84/device2025-11: 8 reports for this device; peer average 1.9/device2025-12: 6 reports for this device; peer average 1.99/device2026-01: 2 reports for this device; peer average 2.04/device2026-02: 2 reports for this device; peer average 1.83/device2026-03: 6 reports for this device; peer average 1.98/device2026-04: 4 reports for this device; peer average 2.12/device2026-05: 10 reports for this device; peer average 1.92/device2026-06: 2 reports for this device; peer average 1.88/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0122.72
2019-0202.45
2019-0312.79
2019-0422.65
2019-0512.07
2019-0611.85
2019-0721.73
2019-0812.19
2019-0912.2
2019-1002.5
2019-1102.2
2019-1202.55
2020-0113.08
2020-0202.52
2020-0303.17
2020-0422.37
2020-0502.26
2020-0602.13
2020-0702.62
2020-0802.21
2020-0902.8
2020-1002.76
2020-1142.4
2020-1222.47
2021-0102.52
2021-0222.24
2021-0302.2
2021-0402.17
2021-0522.19
2021-0602.49
2021-0702.58
2021-0802.56
2021-0902.75
2021-1002.46
2021-1102.22
2021-1202.46
2022-0102.31
2022-0202.33
2022-0302.38
2022-0402.3
2022-0502.46
2022-0602.32
2022-0702.32
2022-0822.33
2022-0902.44
2022-1002.4
2022-1102.48
2022-1202.48
2023-0102.63
2023-0202.34
2023-0302.47
2023-0442.44
2023-0502.35
2023-0662.45
2023-0712.31
2023-0812.02
2023-0932.04
2023-1031.8
2023-1121.78
2023-1221.89
2024-0111.84
2024-0202.21
2024-0312.01
2024-0411.91
2024-0512.24
2024-0622
2024-0711.82
2024-0812.05
2024-0942.05
2024-1041.87
2024-1141.99
2024-1221.71
2025-0162.18
2025-0251.66
2025-0321.85
2025-0401.95
2025-0541.94
2025-0631.97
2025-0761.92
2025-0821.94
2025-0931.75
2025-1001.84
2025-1181.9
2025-1261.99
2026-0122.04
2026-0221.83
2026-0361.98
2026-0442.12
2026-05101.92
2026-0621.88
This device (reports/month)Average device in LZO (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K112115 — cites (transitively): K071535 (d1), K072857 (d1), K073337 (d1), K082792 (d1), K083558 (d1), K083762 (d1), K093944 (d1), K100412 (d1), K103189 (d1), K080885 (d2), K082844 (d2) — cited as predicate by K150007, K160895, K170845, K173776, K181254, K183582, K201673, K202730, K203041, K210263, K220405, K251166

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Medacta International SA

  • VAI 2024-11-19 Medacta International, SA · 1 citations
  • VAI 2024-11-19 Medacta International SA · 0 citations
  • VAI 2024-11-19 Medacta International, SA · 1 citations
  • VAI 2024-11-19 Medacta International SA · 0 citations
  • VAI 2017-06-19 Medacta International SA · 0 citations
  • VAI 2017-06-19 Medacta International SA · 0 citations
  • VAI 2017-02-17 Parcus Medical, LLC · 2 citations
  • OAI 2015-02-05 Medacta International SA · 8 citations
  • OAI 2015-02-05 Medacta International SA · 8 citations
  • VAI 2013-08-16 Parcus Medical, LLC · 1 citations
  • VAI 2010-01-28 Medacta International SA · 0 citations
  • VAI 2010-01-28 Medacta International SA · 0 citations