PINNACLE 1218-32-752Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS GVF POLYETHYLENE CONSTRAINED ACETABULAR LINER +4 10 DEGREE 32mm ID 52mm OD · Class 2 · Implant
All models of PINNACLE (182)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Pinnacle constrained hip liner is a plastic cup liner used in total hip replacement. Most of the 50 reports describe the liner or hip coming out of place (dislocation), often needing repeat surgery to exchange the liner and ball, plus some infections and fractures; 46 injuries and no deaths are reported. No recalls name 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
- 50
- Deaths reported
- 0
- Injuries reported
- 46
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10603295011996), received between Jun 29, 2017 and Aug 27, 2026 — classified as 46 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (27 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated27
- Adverse Event Without Identified Device or Use Problem11
- Fracture6
- Insufficient Device Problem Information3
- Difficult to Insert2
- Appropriate Device Problem Term/Code Not Available1
- Device Damaged Prior to Use1
- Disassembly1
Patient problems
- Joint Dislocation27
- No Code Available14
- Unspecified Infection8
- Insufficient Information3
- Not Applicable3
- Fall2
- Joint Laxity2
- Bone Notching1
Recent adverse event reports
The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2026Device Dislodged or Dislocated
It was reported that Patient suffered a dislocation. Dr informed me that the patient would like to perform a head and liner exchange. The patient was already implanted with a DePuy constrained liner and 32 +5 TS ceramic head. Those components were removed. Dr was unsure of when that revision took place or when the original surgery date was. Once those implants were removed, a new constrained liner was opened and implanted. The patient opted to go with a +4 neutral constrained liner this time as opposed to the +4/10 degree. A new TS 32+5 head was implanted and reduced. Stability was confirmed and the closing process began. No delays or adverse events took place.Activity Level - Yes.DOI-Unknown.DOR-(b)(6)2026.Affected side-Right.
Patient problems: Joint Dislocation
MAUDE report 50475775 ↗InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A HEAD LINER EXCHANGE WAS PERFORMED TO ADDRESS A LEG LENGTH DISCREPANCY FOLLOWING A REVISION TOTAL HIP ARTHROPLASTY. ALL COMPONENTS WERE FOUND TO BE WELL FIXED AND WELL FUNCTIONING. THERE WAS SIGNIFICANT STAINING IN THE JOINT DUE TO CONTACT FROM THE NECK OF THE FEMORAL PROSTHESIS WHICH SHOWED NOTCHING ON THE NECK POSTERIORLY. AS SUCH A NEUTRAL CONSTRAINED LINER AND LONGER BALL WAS CHOSEN FOR REVISION WITH WHICH THE FEMORAL STEM NO LONGER CONTACTED THE RETAINING RING WITH RANGE OF MOTION INTRAOPERATIVELY. DOI: (B)(6) 2022. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.
Patient problems: Bone Notching; Physical Asymmetry
MAUDE report 25052504 ↗InjuryMar 11, 2026Device Dislodged or Dislocated
PATIENT WAS REVISED WITH POLY AND HEAD EXCHANGE DUE TO DISLOCATION. THERE WAS NO SURGICAL DELAY AND NO HARM TO PATIENT. NO BROKEN INSTRUMENT WAS REPORTED. DOI: (B)(6) 2019. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 24570155 ↗InjuryFeb 5, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE DISLOCATION WITH OPEN REDUCTION. LINER AND HEAD EXCHANGED. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 24268067 ↗InjuryNov 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISLOCATION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 23617255 ↗InjurySep 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THE SURGEON REPLACED CONSTRAINED THE LINER OF THE PATIENT. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 22973631 ↗InjuryJun 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED AND SURGEON EXPLANTED DUE TO DISLOCATION. THE HEAD DISLOCATED FROM THE CONSTRAINED LINER. NO REPLACEMENTS ARE NEEDED. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Joint Dislocation
MAUDE report 22286200 ↗InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD A HEAD AND LINER EXCHANGE DUE TO INFECTION. DOI: UNK. DOR: (B)(6) 2025. AFFECTED AREA: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 22062635 ↗InjuryApr 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DISLOCATED HIP WAS SWAPPED TO A NEW CONSTRAINED LINER. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 21873207 ↗InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT'S HEAD AND LINER WERE REMOVED AND REPLACED BECAUSE OF INFECTION. DOI: (B)(6) 2025 DOR: (B)(6) 2025 . AFFECTED SIDE: UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 21738969 ↗InjuryMar 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED AND UNDERWENT CONSTRAINED LINER PLUS 4 NEUTRAL EXCHANGE FOR CONSTRAINED LINER +410°. THE SURGICAL DELAY IS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Joint Dislocation
MAUDE report 21624998 ↗InjuryNov 13, 2024Adverse 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 INFECTED HIP, REQUIRING A HEAD AND LINER EXCHANGE. THERE WAS NO DELAY, AND THERE WERE NO ADVERSE CONSEQUENCES. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 20674572 ↗InjuryOct 24, 2024Fracture; Fracture
IT WAS REPORTED THAT THE CUP WAS IN A VERY VERTICAL ORIENTATION AND THE LOCKING RING FOR THE CONSTRAINED LINER BROKE. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN HIP SIDE.
Patient problems: Insufficient Information
MAUDE report 20521395 ↗InjuryFeb 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED AS THE LOCKING RING WAS DISLODGED DUE TO IMPINGEMENT. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Laxity
MAUDE report 18640431 ↗InjuryDec 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT CONTINUED TO DISLOCATE AFTER CONSTRAINED WAS IMPLANTED. SURGEON SUSPECTS IT¿S BECAUSE OF THE SPINAL FUSION THE PATIENT HAS AND NEEDED TO CHANGE THE CUP OUT. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Joint Dislocation
MAUDE report 18363461 ↗InjuryJul 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. DOI: UNKNOWN, DOR: ON (B)(6) 2023, AFFECTED SIDE: UNKNOWN HIP SIDE.
Patient problems: Joint Dislocation
MAUDE report 17361502 ↗InjuryMar 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
REVISION COMPLETED DUE TO DISLOCATION. LINER WAS REMOVED AND REPLACED WITH A DIFFERENT PRODUCT. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 13690624 ↗InjuryFeb 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENTS WAS REVISED DUE TO FELL AND DISLOCATED HIP. SURGEON EXPLANTED A 32X52 +4 10 DEGREE CONSTRAINED PINNACLE LINER AND A 32 +9 DELTA CERAMIC HEAD. I HAVE NO FURTHER INFORMATION ON THIS CASE OR PATIENT. DOI: UNKNOWN ; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.
Patient problems: Fall; Joint Dislocation
MAUDE report 13543051 ↗InjuryJan 25, 2022Adverse 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 INSTABILITY. DOI: (B)(6) 2021; DOR: (B)(6) 2022; LEFT HIP.
Patient problems: Joint Laxity
MAUDE report 13343464 ↗InjuryJan 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT FELL AND DISLOCATED HIP SO THE DOCTOR PUT IN NEW HEAD AND LINER. DOI: (B)(6) 2019. DOR: (B)(6) 2021. AFFECTED SIDE: LEFT HIP.
Patient problems: Fall; Joint Dislocation
MAUDE report 13192822 ↗InjuryNov 22, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT DISLOCATED OUT OF CONSTRAINED LINER. DOI: OVER 10 YEARS AGO, DOR: (B)(6) 2021, LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 12852619 ↗InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO IMPINGEMENT ON POLY WHICH CREATED FAILURE. DOI: UNKNOWN, DOR: (B)(6) 2021, (RIGHT HIP).
Patient problems: Failure of Implant
MAUDE report 12563431 ↗MalfunctionFeb 1, 2021Difficult to Insert; Difficult to Insert
THE PATIENT WAS REVISED TO ADDRESS UNSTABLE HIP, SURGEON EXPLANTED LINER REVISING WITH CONSTRAINED PINNACLE LINER. WHEN SURGEON IMPLANTED THE NEW CONSTRAINED LINER HE OBSERVED THAT ALL THE ARD TABS WERE .5MM PROUD OF THE FACE OF THE CUP. A SECOND LINER WAS CALLED FOR, OPENED AND IMPLANTED. AGAIN, ALL THE TABS WERE .5MM PROUD. THE SURGEON FELT THE LINER WAS STABLE WITH THE SECONDARY RING HOLDING IT IN PLACE, SO HE CONTINUED ON WITH THE PROCEDURE. HE ASKED FOR A RESPONSE FROM DEPUY REGARDING THIS MATTER. SURGICAL DELAY: 5MINS. DOI: UNKNOWN - DOR: (B)(6) 2012 (LEFT HIP).
Patient problems: Insufficient Information
MAUDE report 11262823 ↗MalfunctionFeb 1, 2021Difficult to Insert; Difficult to Insert
THE PATIENT WAS REVISED TO ADDRESS UNSTABLE HIP, SURGEON EXPLANTED LINER REVISING WITH CONSTRAINED PINNACLE LINER. WHEN SURGEON IMPLANTED THE NEW CONSTRAINED LINER HE OBSERVED THAT ALL THE ARD TABS WERE .5MM PROUD OF THE FACE OF THE CUP. A SECOND LINER WAS CALLED FOR, OPENED AND IMPLANTED. AGAIN, ALL THE TABS WERE .5MM PROUD. THE SURGEON FELT THE LINER WAS STABLE WITH THE SECONDARY RING HOLDING IT IN PLACE, SO HE CONTINUED ON WITH THE PROCEDURE. HE ASKED FOR A RESPONSE FROM DEPUY REGARDING THIS MATTER. SURGICAL DELAY: 5MINS. DOI: UNKNOWN - DOR: (B)(6) 2012 (LEFT HIP).
Patient problems: Insufficient Information
MAUDE report 11262646 ↗InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REVISED FOR PAINFUL LEFT TOTAL HIP REPLACEMENT.
Patient problems: No Code Available; Pain
MAUDE report 10620341 ↗
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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