KXDClass IIIImplant
Prosthesis, Hip, Constrained, Metal
Orthopedic · 21 CFR 888.3300
Call for PMAs 12/26/96 (61 FR 50709 (9/27/96))
MDR events8All time
Recalls0All time
Registered firms3Currently listed
510(k) clearances0All time
Recent MDR events
8 adverse event reports on file
- PLASMAFIT POLY CUP SIZE 52MM HSep 28, 2022InjuryAesculap Ag9610612-2022-00284
- COLLECT.NO.QAS HIP STEMS METHAJul 13, 2018MalfunctionAesculap Implant Systems9610612-2018-00320
- COLLECT.NO.QAS HIP STEMS METHAJul 13, 2018MalfunctionAesculap Implant Systems9610612-2018-00319
- PROSTHESIS, HIP, CONSTRAINED, METALJun 22, 2018Injury7632336
- NOVATIONMay 28, 2013OtherExactech Inc1038671-2013-00048
- PLUSJun 9, 2009InjuryAarau Switzerland Manufacturing Site9613369-2009-00121
- PLUSMay 14, 2009InjuryRotkreuz Switzerland Manufacturing Site9612771-2009-00104
- PLUSMay 14, 2009InjuryRotkreuz Switzerland Manufacturing Site9612771-2009-00105
Event type breakdown
Injury5
Malfunction2
Other1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
3 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.