Microport Orthopedics Inc.
4427 adverse events · 66 recalls · 46 clearances · 6 inspections · 2 compliance actions · aggregated across 3 source records
Scorecard
Events per device across the 24,021-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0.013 ▼
320 in the last 12 months
Higher volume than 88% of companies with 10+ devices
Recalls per device
0.000 →
2 in the last 12 months
Higher volume than 97% of companies with 10+ devices
These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.
Devices
24,021 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|---|---|---|---|
| Profemur | PHA01204 | LWJ MRA | M684PHA012041 | 136 |
| Profemur | PHA01202 | LWJ MRA | M684PHA012021 | 132 |
| PROCOTYL | PHA04416 | LPH LZO | M684PHA044161 | 103 |
| Profemur | PHA01254 | LWJ MRA | M684PHA012541 | 102 |
| Profemur | PHA01252 | LWJ MRA | M684PHA012521 | 100 |
| PROCOTYL | PHA04414 | LZO | M684PHA044141 | 67 |
| PROFEMUR® | PHAC1254 | LPH LZO MBL | M684PHAC12541 | 67 |
| ADVANCE® | KTCCNP30 | HRY | M684KTCCNP301 | 62 |
| Dynasty | DLXPGD36 | JDI LPH MBL | M684DLXPGD361 | 57 |
| Advantim | 18080302 | HWC | M684180803021 | 54 |
| PROCOTYL | PHA04418 | LZO | M684PHA044181 | 52 |
| Profemur | PHA01234 | LWJ MRA | M684PHA012341 | 50 |
| Profemur | PHA01232 | LWJ MRA | M684PHA012321 | 48 |
| ADVANCE® | KTCCNP40 | HRY | M684KTCCNP401 | 45 |
| Evolution | EIS6S10R | HRY JWH | M684EIS6S10R1 | 42 |
| ADVANCE® | KPONTP35 | JWH | M684KPONTP351 | 41 |
| PROFEMUR® | PHAC1252 | LPH LWJ LZO MBL | M684PHAC12521 | 39 |
| Profemur | PHAC1252 | LPH LZO MBL | 00192629087354 | 39 |
| ADVANCE® | KFTCNP3R | JWH | M684KFTCNP3R1 | 38 |
| Evolution | EIS5S10L | HRY JWH | M684EIS5S10L1 | 38 |
| GUARDIAN® | 25002100 | JDI KRO | M684250021001 | 38 |
| PROCOTYL | PHA04410 | LPH LZO | M684PHA044101 | 38 |
| Profemur | PHA01244 | LWJ MRA | M684PHA012441 | 38 |
| Evolution | EIS5S10R | HRY JWH | M684EIS5S10R1 | 37 |
| Dynasty | DSBFGD52 | JDL KWA | M684DSBFGD521 | 36 |
| PROCOTYL | PHA04406 | LPH LZO | M684PHA044061 | 36 |
| ADVANCE® | KTCCNP20 | HRY | M684KTCCNP201 | 33 |
| PROCOTYL | PHA04402 | LPH LZO | M684PHA044021 | 32 |
| Profemur | PHA01222 | LWJ MRA | M684PHA012221 | 30 |
| TRANSCEND® | 26000026 | JDL KWA | M684260000261 | 30 |
Showing 1–30 of 24,021Next →
Compliance actions
FDA warning letters and enforcement actions (full history).
| Date | Type | Action | Firm |
|---|---|---|---|
| 2015-06-17 | WL | Warning Letter | MicroPort Orthopedics Inc. |
| 2015-06-17 | WL | Warning Letter | MicroPort Orthopedics Inc. |
Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|---|---|---|---|
| 3010536692 | MICROPORT ORTHOPEDICS INC. | Arlington, TN, US | NAI | |
| 3010856250 | Microport Orthopedics, S.A. | Sabana Norte San Jose, CR | — |