PINNACLE 1218-32-756Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS GVF POLYETHYLENE CONSTRAINED ACETABULAR LINER +4 10 DEGREE 32mm ID 56mm OD · Class 2 · Implant
All models of PINNACLE (182)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295012016), received between Sep 1, 2022 and Sep 1, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Fracture1
Patient problems
- Foreign Body Reaction1
- Joint Dislocation1
- Joint Laxity1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 1, 2022Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated
REVISION COMPLETED DUE HIP PAIN AND DYSFUNCTION, LARGE FRAGMENTS OF POLY (DETERMINED AS "PETALS" OF LOCKING BORE OF CONSTRAINED LINER) AND METALLOSIS PRESENT, LOCKING RING LOOSE/DISENGAGED, DISLOCATION WITHOUT DIFFICULTY. ORIGINAL STEM AND CUP FROM 2014 REVISION STABLE AND LEFT IN-SITU. SURGEON AWARE THAT SKIRTED HEAD SHOULD NOT BE USED WITH CONSTRAINED LINER AND WAS CAUSE OF FAILURE. PREVIOUS REVISION COMPLETED DUE TO INSTABILITY/DISLOCATION.
Patient problems: Foreign Body Reaction; Joint Dislocation; Joint Laxity; Pain
MAUDE report 15336820 ↗
Other Prosthesis, hip, constrained, cemented or uncemented, metal/polymer devices
- Novation 134-36-45Exactech, Inc. · Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer2 recalls0 reports
- PINNACLE 1218-28-650Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer89 reports
- Trident 690-00-28FHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall37 reports
- Trident 690-00-22EHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall36 reports
- PINNACLE 1218-32-652Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer75 reports
- Trident 690-00-22DHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall22 reports
- PINNACLE 1218-32-654Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer70 reports
- Trident 69-2850Howmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall11 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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