PINNACLE 1218-32-664Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS GVF POLYETHYLENE CONSTRAINED ACETABULAR LINER +4 NEUTRAL 32mm ID 64mm OD · Class 2 · Implant
All models of PINNACLE (182)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295011927), received between Jun 6, 2018 and Aug 21, 2019 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Code Available3
- Joint Dislocation2
- Unspecified Infection2
- Not Applicable1
- Test Result1
- Tissue Damage1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
PPF AND IMPLANT RECORDS RECEIVED. PPF ALLEGES DISLOCATION, INFECTION AND ELEVATED METAL IONS. DOI: (B)(6) 2006, ( CUP. SCREWS AND STEM); DOI: (B)(6) 2009, (HEAD AND LINER); DOR: NOT REPORTED, (RIGHT HIP).
Patient problems: Joint Dislocation; No Code Available; Test Result; Unspecified Infection
MAUDE report 8916942 ↗InjuryMay 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PPF HAS NO ALLEGATION REPORTED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS INFECTION AND FAILURE OF SKIN HEALING ON THE RIGHT LATERAL HIP. REVISION NOTE REPORTED OF MURKY FLUID WITHIN THE JOINT ITSELF SURROUNDED WITH THICK YELLOW PUS. THE SURGEON WAS ALSO REPORTED OF RESIDUAL METALLIC DEBRIS AND ALVAL TISSUE IN THE POSTERIOR MEDIAL FEMORAL CORTEX. DOI: (B)(6) 2013; DOR: (B)(6) 2013 (RIGHT HIP) FOURTH REVISION.
Patient problems: No Code Available; Tissue Damage; Unspecified Infection
MAUDE report 8596235 ↗InjuryJun 6, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT HIP.
Patient problems: Joint Dislocation; No Code Available; Not Applicable
MAUDE report 7572887 ↗
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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