PINNACLE 1218-32-654Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS GVF POLYETHYLENE CONSTRAINED ACETABULAR LINER +4 NEUTRAL 32mm ID 54mm OD · Class 2 · Implant
All models of PINNACLE (182)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Pinnacle constrained polyethylene hip liner is a cup insert used in total hip replacement. Most of the 71 reports describe the hip coming apart after surgery — the ball slipping or levering out of the liner, and in some cases the whole cup shifting or the liner pulling free — leading to pain and revision operations; a few mention worn or fractured parts. Reports describe 69 injuries and no deaths. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 70
- Deaths reported
- 0
- Injuries reported
- 68
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 10603295011873), received between Jun 28, 2017 and Jul 27, 2026 — classified as 68 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (49 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.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated49
- Adverse Event Without Identified Device or Use Problem12
- Insufficient Device Problem Information5
- Fracture4
- Naturally Worn3
- Difficult to Remove1
- Material Rupture1
- Off-Label Use1
Patient problems
- Joint Dislocation47
- No Code Available15
- Pain8
- Unspecified Infection7
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Insufficient Information4
- Limited Mobility Of The Implanted Joint3
- Anxiety2
Recent adverse event reports
The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Device Dislodged or Dislocated
It was reported that patient head came out of the constrained liner. Dr. replaced the constrained liner and added a longer head for stability. There was no mention of issues with the implants. The surgeon thought the head levered out due to not having a long enough offset.DOI-(b)(6) 2025.DOR-(b)(6) 2026.Affected side-Unknown.
Patient problems: Joint Dislocation
MAUDE report 50045293 ↗InjuryJul 27, 2026Device Dislodged or Dislocated
It was reported that the patient was revised due to dislocated left total hip. Revised cup to Emphasys cup with dual mobility.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Left hip.
Patient problems: Joint Dislocation
MAUDE report 50036505 ↗InjuryJun 1, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT WAS REVISED AS THEY HAD DISLOCATED THROUGH CONSTRAINED LINER. OUTER CONSTRAINING RING REMAINED AND HEAD PULLED THROUGH IT. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Joint Dislocation
MAUDE report 25351100 ↗InjuryNov 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE CUP MOVED CAUSING HIP TO DISLOCATE AND PULLING CONSTRAINED LINER OUT OF THE CUP. THIS PATIENT HAS HAD MULTIPLE HIP REVISIONS ON THIS HIP. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 23570207 ↗InjuryOct 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF J&J CORAIL STEM AND PINNACLE CUP FOR DISLOCATION. IT WAS REPORTED THAT THE ISSUE WAS WITH THE POSITIONING OF THE CUP AND STEM FROM THE PRIMARY PROCEDURE.
Patient problems: Joint Dislocation
MAUDE report 23427053 ↗InjuryOct 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Joint Dislocation
MAUDE report 23424995 ↗InjuryOct 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED DUE TO DISLOCATION. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 23402453 ↗InjurySep 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO DISLOCATION. NO FURTHER INFORMATION AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 22940536 ↗InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. AFFECTED SIDE: UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 22518610 ↗InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS INFECTED AND SURGEON PERFORMED A HIP I&D WITH HEAD/LINER EXCHANGE. THERE WERE NO DELAYS OR COMPLAINTS. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 22385629 ↗InjuryApr 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 21881703 ↗InjuryFeb 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO A DISLOCATED HIP. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2019. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 21445368 ↗InjuryNov 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. THE PROXIMAL FEMUR DISLOCATED OUT OF THE CONSTRAINED LINER. REVISING THE LINER WITH A 10 DEGREE LIPPED LINER. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 20747527 ↗InjuryJul 15, 2024Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn
ADDITIONAL INFORMATION WAS RECEIVED: A. WAS THERE ANY PATIENT HARM/CONSEQUENCE RELATED TO THE EVENT? NO.
Patient problems: Joint Dislocation
MAUDE report 19741438 ↗InjurySep 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED DUE TO RECURRENT DISLOCATION OF THE RIGHT HIP. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 17780153 ↗InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INFECTION AND ALL IMPLANTS WERE REMOVED. DOI: (B)(6), DOR: (B)(6), AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 16743579 ↗InjuryMar 27, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO HIP DISLOCATION. SURGEON EXPLANTED CONSTRAINED LINER AND REVISED COMPETITIVE PROX BODY. NEW CONSTRAINED INSERT WAS USED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 16618490 ↗InjuryOct 22, 2022Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated
REVISION COMPLETED DUE TO FAILED CONSTRAINED LINER. HEAD DISLOCATED FROM POLY LINER. SURGERY TIME EXTENDED DUE TO DIFFICULTY REMOVING LINER FROM CUP. THERE WAS A SURGICAL DELAY OF 30 MINUTES. DOI: (B)(6) 2016. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 15656259 ↗InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT UNDERWENT PRIMARY TOTAL HIP REPLACEMENT SURGERY ON THEIR LEFT HIP ON THE (B)(6) 2016. THE PATIENT PRESENTED BACK TO SURGEON AND WAS REVISED FOR AN UNKNOWN REASON ON THE (B)(6) 2017. THE PATIENT WAS REVISED AGAIN FOR AN UNKNOWN REASON ON THE (B)(6) 2017.
Patient problems: Insufficient Information
MAUDE report 14948333 ↗InjuryMar 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT NO RECORDS PREVIOUS WERE AVAILABLE ON PATIENT¿S PREVIOUS SURGERY BUT SURGEON BELIEVES IT WAS APPROXIMATELY 2010. PATIENT REPORTS DISLOCATED HIP IN SEPARATE CITY THE PREVIOUS WEEKEND. THIS COMPLAINT WAS CREATED TO CAPTURE THE DISLOCATION THAT WAS MENTIONED IN THE EVENT DESCRIPTION UNDER (B)(4). DOI: UNKNOWN, AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 13900528 ↗InjuryMar 23, 2022Fracture; Naturally Worn; Fracture; Naturally Worn
IT WAS REPORTED THAT NO RECORDS PREVIOUS WERE AVAILABLE ON PATIENT¿S PREVIOUS SURGERY BUT SURGEON BELIEVES IT WAS APPROXIMATELY 2010. PATIENT REPORTS DISLOCATED HIP IN SEPARATE CITY THE PREVIOUS WEEKEND. SURGEON REVIEWED RELOCATED XRAY AND IS CONCERNED WITH ¿NEW¿ COMPONENT POSITION. PATIENT BROUGHT TO OR FOR HEAD AND LINER EXCHANGE. CONSTRAINED RETAINING RING FOUND TO OFF OF CONSTRAINED LINER AND LINER HAD BROKEN POLYETHYLENE ON THE PERIPHERY OF THE CONSTRAINING PORTION OF THE LINER. HEAD AND LINER WERE REMOVED AND REPLACED AFTER CONFIRMING SIZES. SURGEON FELT THAT POLY HAD LIKELY FAILED DUE TO BRITTLENESS FROM OXIDATION OVER TIME. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6), 2022. AFFECTED SIDE: RIGHT HIP.
Patient problems: Insufficient Information
MAUDE report 13868662 ↗InjuryDec 14, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT DISLOCATED HER SPACER. PATIENT IS IN POOR HEALTH AND HAS DEMENTIA AND DID NOT FOLLOW HIP PRECAUTIONS. SURGEON CHOOSE TO REMOVE AND REPOSITION CEMENTED LINER. CEMENT WAS A DEPUY PRODUCT, BUT HOSPITAL OWNED, SO NO PART, LOT, OR QTY INFO IS AVAILABLE. DOI: (B)(6) 2021, DOR: (B)(6) 2021 , RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 13001458 ↗InjuryNov 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE CONSTRAINED LINER AND SHELL PULLED OUT OF THE ACETABULUM. REVISED TO REV CUP WITH SCREWS AND NEUTRAL ALTRX LINER. NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2021, AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Insufficient Information
MAUDE report 12778486 ↗InjurySep 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT DISLOCATED HIS CONSTRAINED LINER. WE REMOVED THE CONSTRAINED LINER AND FEMORAL HEAD AND REPLACED WITH NEW CONSTRAINED LINER AND FEMORAL HEAD. DOI: (B)(6) 2021, DOR: (B)(6) 2021 , (UNKNOWN SIDE).
Patient problems: Joint Dislocation
MAUDE report 12547673 ↗InjurySep 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
COMPASS CASE (B)(4) REPORT: IT WAS REPORTED THAT THE PATIENT HAD A PINNACLE CUP WITH A PINNACLE CONSTRAINED LINER. THEY WERE BEING REVISED DUE TO DISLOCATION. THE CONSTRAINED LINER WAS REMOVED AND A PINNACLE DUAL MOBILITY LINER AND BIMENTUM DUAL MOBILITY LINER WERE IMPLANTED.
Patient problems: Joint Dislocation
MAUDE report 12438233 ↗
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
- Trident 69-2850Howmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall11 reports
- Trident 690-00-28GHowmedica 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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