PINNACLE 1218-32-758Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS GVF POLYETHYLENE CONSTRAINED ACETABULAR LINER +4 10 DEGREE 32mm ID 58mm OD · Class 2 · Implant
All models of PINNACLE (182)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295012023), received between Aug 28, 2018 and Oct 14, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Naturally Worn” (2 reports).
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 18, 2026.
Most reported problems
Device problems
- Naturally Worn2
- Migration or Expulsion of Device1
Patient problems
- No Consequences Or Impact To Patient2
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 14, 2019Naturally Worn; Naturally Worn
CLINICAL ADVERSE EVENT RECEIVED FOR ABNORMAL X-RAY - POLYWEAR. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2012 (CUP, LINER, SCREWS -- STEM & HEAD UNKNOWN). DATE OF EVENT: (B)(6) 2018. (LEFT HIP).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9187513 ↗InjuryAug 28, 2018Migration or Expulsion of Device; Naturally Worn; Migration or Expulsion of Device; Naturally Worn
(B)(6). ASSOCIATED STUDY: DOTS. CLINICAL ADVERSE EVENT NOTIFICATION RECEIVED FOR ABNORMAL RADIOGRAPHIC EVALUATION- POLYWEAR. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD IN SEVERITY. EVENT IS RELATED TO BOTH DEVICE AND PROCEDURE. DOE: (B)(6) 2018; DOI: (B)(6) 2012; (LEFT HIP). FOLLOWING XRAYS.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 7822913 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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