Medacta International SA

8454 adverse events · 40 clearances · 12 inspections · aggregated across 4 source records

Scorecard

Events per device across the 31,550-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.

MAUDE reports per device

0.035 ▼

1,104 in the last 12 months

Higher volume than 90% of companies with 10+ devices

Recalls per device

0 →

0 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

31,550 device records · ordered by linked event volume.

Brand	Model	Product codes	Primary DI	Linked events
Mectacer Biolox Delta Femoral Ball Head	01.29.209	LZO	07630030809200	162
AMIStem H Femoral Stems	01.18.133	LZO MEH	07630030804090	145
Mectacer Biolox Delta Femoral Ball Head	01.29.208	LZO	07630030809194	141
AMIStem H Femoral Stems	01.18.132	LZO MEH	07630030804083	140
GMK Sphere Total Knee System	02.12.0510FR	JWH	07630030826740	140
GMK Sphere Total Knee System	02.12.0410FR	JWH	07630030826542	133
GMK Sphere Total Knee System	02.12.0410FL	JWH	07630030826535	131
Mpact Acetabular System	01.32.3644HCT	LPH LZO	07630030812118	130
Shoulder System	04.01.0110	PHX	07630040706179	117
Shoulder System	04.01.0122	PHX	07630040706292	108
GMK Sphere Total Knee System	02.12.E0410FR	JWH	07630971261761	102
GMK Primary Total Knee System	02.07.1204R	JWH	07630030819919	100
Mectacer Biolox Delta Femoral Ball Head	01.29.204	LZO	07630030809156	100
GMK Primary Total Knee System	02.07.1205R	JWH	07630030819933	97
GMK Sphere Total Knee System	02.12.0310FL	JWH	07630030826337	95
AMIStem H Femoral Stems	01.18.131	LZO MEH	07630030804076	92
GMK Sphere Total Knee System	02.12.0510FL	JWH	07630030826733	92
GMK Sphere Total Knee System	02.12.0310FR	JWH	07630030826344	91
Shoulder System	04.01.0173	PHX	07630040706605	89
GMK Primary Total Knee System	02.07.1202R	JWH	07630030819872	87
Shoulder System	04.01.0119	PHX	07630040706261	87
GMK Primary Total Knee System	02.07.1204L	JWH	07630030819902	86
Mectacer Biolox Delta Femoral Ball Head	01.29.210	LZO	07630030809217	85
Double Mobility Liner	01.26.2850MHC	MEH	07630030807282	84
Mpact Acetabular System	01.32.3648HCT	LPH LZO	07630030812132	84
Shoulder System	04.01.0123	PHX	07630040706308	82
AMIStem H Femoral Stems	01.18.134	LZO MEH	07630030804106	81
GMK Primary Total Knee System	02.07.1203R	JWH	07630030819896	79
GMK Primary Total Knee System	02.07.1205L	JWH	07630030819926	77
GMK Sphere Total Knee System	02.12.E0510FR	JWH	07630971262003	75

Showing 1–30 of 31,550Next →

Facilities

Registered establishments with their latest FDA inspection outcome.

FEI	Name	Location	Last inspection
3005180920	MEDACTA INTERNATIONAL SA	Castel San Pietro Ticino, CH	VAI
3008110533	MEDACTA INTERNATIONAL SA	Rancate Ticino, CH	VAI
3007319107	PARCUS MEDICAL , L.L.C.	Sarasota, FL, US	VAI