HRZClass IIIImplant
Prosthesis, Knee, Hinged (metal-metal)
Orthopedic · 21 CFR 888.3480
PMAs to be filed by 12/26/96 (61 FR 50710 (9/27/96))
MDR events88All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances0All time
Recent MDR events
88 adverse event reports on file
- COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGEJul 9, 2025InjuryAesculap Ag9610612-2025-00136
- COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGEMay 9, 2025InjuryAesculap Ag3005673311-2025-00039
- COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGEApr 22, 2025InjuryAesculap Ag9610612-2025-00065
- COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGEFeb 11, 2025InjuryAesculap Ag9610612-2025-00034
- METAL KNEECAP IMPLANTJul 24, 2023InjuryUnknownMW5120089
- 11MM MC TIBIAL INSERT WITH LOCKING MECHANISM VERIFIEDOct 14, 2022InjuryZimmer Biomet, Inc.0001822565-2022-02927
- COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGEAug 10, 2022InjuryAesculap Ag9610612-2022-00238
- MUTARS®Apr 1, 2020InjuryImplantcast Gmbh3012523063-2020-00003
- MUTARS®Dec 17, 2019InjuryImplantcast Gmbh3012523063-2019-00016
- ROTATING HINGED TOTAL KNEE PROSTHESISMar 11, 2019InjuryWaldemar Link Gmbh & Co. Kg3006721341-2019-00003
Event type breakdown
Injury77
Malfunction10
Other1
Most-reported manufacturers
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.