HSAClass IIIImplant
Prosthesis, Knee, Hemi-, Femoral
Orthopedic · 21 CFR 888.3570
MDR events2,314All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances0All time
Recent MDR events
2,314 adverse event reports on file
- UNKNOWN APEX 3D TIBIAL COMPONENTFeb 23, 2026InjuryParagon 283008650117-2026-00049
- UNKNOWN COMPONENT OF AESCULAP AG VEGA KNEE IMPLANT SYSTEMDec 11, 2025InjuryAesculap Ag9610612-2025-00294
- U2 TOTAL KNEE SYSTEMApr 15, 2025InjuryUnited Orthopedic Corporation3009760038-2025-00001
- UNKNOWN OXFORD BEARINGJul 26, 2022InjuryBiomet Uk Ltd.3002806535-2022-00338
- UNKNOWN OXFORD FEMORAL COMPONENTJul 26, 2022InjuryBiomet Uk Ltd.3002806535-2022-00340
- UNKNOWN OXFORD TIBIAL TRAYJul 26, 2022InjuryBiomet Uk Ltd.3002806535-2022-00339
- UNKNOWN 10 PS PLUS ARTICULAR SURFACEJul 25, 2022InjuryZimmer Biomet, Inc.0001825034-2022-01703
- METHA ¿CAP 12/14 130°/0° SIZE 1May 23, 2017MalfunctionAesculap Implant Systems9610612-2017-00293
- METHA ¿CAP 12/14 130°/0° SIZE 2May 23, 2017MalfunctionAesculap Implant Systems9610612-2017-00294
- INBONE®Mar 1, 2017MalfunctionWright Medical Technology, Inc.1043534-2017-00024
Event type breakdown
Injury1,989
Malfunction233
Other75
Unspecified16
Death1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.