JDHClass IIIImplant
Prosthesis, Hip, Hemi-, Trunnion-bearing, Femoral, Metal/polyacetal
Orthopedic · 21 CFR 888.3380
MDR events2,621All time
Recalls1All time
Registered firms0Currently listed
510(k) clearances0All time
Recent MDR events
2,621 adverse event reports on file
- R3 32MM ID INTL DLT CER LNR 48MMJul 11, 2025InjurySmith & Nephew, Inc.1020279-2025-01224
- UNKN TANDEM BIPOLAR FEM HEADOct 30, 2024InjurySmith & Nephew, Inc.1020279-2024-02253
- NV CROWN CUP NO HOLE 58MM GROUP 3Jul 8, 2024InjuryExactech, Inc.1038671-2024-02315
- NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPSJul 8, 2024InjuryExactech, Inc.1038671-2024-02317
- UNKN ORTHOPAEDIC RECONSTRUCTION DEVMay 16, 2024InjurySmith & Nephew, Inc.1020279-2024-00956
- UNKN ORTHOPAEDIC RECONSTRUCTION DEVMay 16, 2024InjurySmith & Nephew, Inc.1020279-2024-00957
- UNKN ORTHOPAEDIC RECONSTRUCTION DEVApr 18, 2024InjurySmith & Nephew, Inc.1020279-2024-00769
- R3 LINER IMPACTOR HEAD 32MMSep 25, 2023MalfunctionSmith & Nephew, Inc.1020279-2023-01843
- UNKN SYNERGY HIP STEMSep 7, 2023InjurySmith & Nephew, Inc.1020279-2023-01742
- UNKN JOURNEY BCS / JOURNEY II BCS KNEE INSERTSep 4, 2023InjurySmith & Nephew, Inc.1020279-2023-01716
Event type breakdown
Injury2,516
Malfunction88
Unspecified12
Death4
Other1
Product problems
Reported product problem codes, most common first
Insufficient Device Problem Information873
Device Dislodged or Dislocated342
Adverse Event Without Identified Device or Use Problem338
Fracture198
Device Slipped141
Break130
Appropriate Device Problem Term/Code Not Available88
Loose or Intermittent Connection73
Trend for “Insufficient Device Problem Information”
No history to chart.
Recalls
1 recall events for this product code
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.