PINNACLE 1218-32-662Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS GVF POLYETHYLENE CONSTRAINED ACETABULAR LINER +4 NEUTRAL 32mm ID 62mm 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295011910), received between Mar 18, 2021 and Nov 17, 2023 — classified as 2 injuries, 1 malfunction.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
- Fracture1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Fatigue1
- Joint Dislocation1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT HAS RECURRENT LEFT HIP DISLOCATIONS. CONSTRAINED LINER AND HEAD WERE REPLACED. SURGEON BELIEVES IT MAY BE MUSCLE WEAKNESS CAUSING DISLOCATIONS.
Patient problems: Fatigue; Joint Dislocation
MAUDE report 18161691 ↗MalfunctionAug 20, 2021Fracture; Fracture
SURGEON REVISED A TOTAL HIP REPLACEMENT AFTER THE PATIENT HAD A FALL AND DISLOCATED HIS HIP. THE LINER WAS CONSTRAINED AND HAD BROKEN INSITU. WHEN SURGEON WAS TRYING TO PUT THE METAL REINFORCEMENT RING OVER THE CONSTRAINED POLY, IT CRACKED. HE REMOVED IT AND HAD TO USE ANOTHER ONE. DOI: UNKNOWN, DOR: (B)(6) 2021, UNKNOWN SIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12347503 ↗InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUP, LINER AND SCREWS WERE IMPLANTED DURING A REVISION PROCEDURE. IT IS UNKNOWN IF THE ORIGINAL IMPLANTS WERE DEPUY. THE PATIENT HAD EXTENSIVE BONE LOSS AND THE FAILED TO OSSEOINTEGRATE WITH THE CUP AND SCREWS THAT WERE IMPLANTED AT REVISION (DOI). A DECISION WAS MADE TO CONVERT TO PROTRUSIO CAGE. DOI: (B)(6) 2021; DOR: (B)(6) 2021 LEFT HIP.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11521323 ↗
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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