KRPClass IIIImplant
Prosthesis, Knee, Patello/femorotibial, Constrained, Cemented, Polymer/metal/metal
Orthopedic · 21 CFR 888.3550
Call for PMAs to be filed by 12/26/96 per 61 FR 50710 on 9/27/96
MDR events62All time
Recalls1All time
Registered firms0Currently listed
510(k) clearances0All time
Recent MDR events
62 adverse event reports on file
- SAIPH CEMENTED PATELLAOct 24, 2025MalfunctionMatortho3016096064-2025-00001
- VANGUARD KNEE SYSTEMApr 9, 2025InjuryZimmer Biomet Holdings, Inc./biomet, Inc.MW5168752
- ZIMMER NEXGEN LEGACYDec 11, 2024InjuryZimmer, Inc.MW5163542
- AXIAL PIN INSERTER/EXTRACTORJan 27, 2020MalfunctionOnkos Surgical3013450937-2020-00007
- AGC DA 2000 TIBIAL TRAY 67MMAug 31, 2017InjuryBiomet Uk Ltd.3002806535-2017-00877
- OXFORD PARTIAL KNEE SYSTEM DOMED LATERAL TIBIAL TRAY SIZE CMar 16, 2017InjuryBiomet Uk Ltd.3002806535-2017-00145
- UNKNOWN DEPUY COMPONENTDec 22, 2016InjuryDepuy Orthopaedics 18189101818910-2016-33863
- TC-PLUSNov 2, 2009InjuryAarau Switzerland Manufacturing Site9613369-2009-00161
- TC-PLUSNov 2, 2009InjuryAarau Switzerland Manufacturing Site9613369-2009-00160
- TC-PLUSNov 2, 2009InjuryAarau Switzerland Manufacturing Site9613369-2009-00159
Event type breakdown
Injury56
Unspecified3
Malfunction3
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.