PINNACLE 1218-32-652Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS GVF POLYETHYLENE CONSTRAINED ACETABULAR LINER +4 NEUTRAL 32mm ID 52mm OD · Class 2 · Implant
Quick summary
This DePuy Pinnacle constrained polyethylene hip liner is a cup insert used in total hip replacement. The 74 reports mostly describe the liner dislocating or coming loose after surgery, along with hip dislocation, cracks in the plastic at the rim, and normal wear that sometimes required revision surgery; reports also mention infection and pain. There are 69 injuries and no deaths. 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
- 75
- Deaths reported
- 0
- Injuries reported
- 70
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 10603295011866), received between Jan 2, 2014 and Sep 29, 2026 — classified as 70 injuries, 5 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated49
- Adverse Event Without Identified Device or Use Problem17
- Fracture7
- Naturally Worn3
- Insufficient Device Problem Information2
- Appropriate Device Problem Term/Code Not Available1
- Connection Problem1
- Device Damaged Prior to Use1
Patient problems
- Joint Dislocation47
- No Code Available17
- Unspecified Infection13
- Not Applicable8
- Pain4
- Joint Disorder3
- No Clinical Signs, Symptoms or Conditions3
- Discomfort2
Recent adverse event reports
The 25 most recent of 75 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Device Dislodged or Dislocated
It was reported that the patient was revised due to dislocation.Affected side: Left hip.
Patient problems: Joint Dislocation
MAUDE report 50931157 ↗MalfunctionMar 26, 2026Fracture
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT ON (B)(6) 2026. THE CONSTRAINED POLY CRACKED AT THE RIM WHEN THE SURGEON TRIED TO REDUCE THE HEAD BALL. DOE: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24703429 ↗InjuryMar 26, 2026Naturally Worn
PATIENT WAS REVISED FOR CONSTRAINED POLY LINER DUE TO POLY WEAR. DOI: (B)(6) 2011. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24703198 ↗InjuryFeb 27, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED WITH HEAD AND LINER EXCHANGE DUE TO DISLOCATION. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 24472413 ↗InjuryJan 16, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT DISLOCATED AND SURGEON REPLACED LINER WITH NEW CONSTRAINED LINER. THERE WAS NO DELAY AND NO PATIENT HARM. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 24099624 ↗InjuryJan 16, 2026Device Dislodged or Dislocated
PATIENT REVISED DUE TO FAILED PINNACLE CONSTRAINED LINER DISLOCATION. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.
Patient problems: Insufficient Information
MAUDE report 24096966 ↗InjuryAug 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO CHRONIC DISLOCATIONS. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 22797491 ↗InjuryJul 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION OF CONSTRAINED LINER. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 22642058 ↗InjuryJun 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD CHRONIC DISLOCATION. PATIENT EXPERIENCED BACK FUSION A FEW YEARS AFTER TOTAL HIP REPLACEMENT. AFFECTED SIDE: UNKNOWN HIP SIDE.
Patient problems: Joint Dislocation
MAUDE report 22230094 ↗InjuryMay 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT DISLOCATED HIP REQUIRING REVISION. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 21992595 ↗InjuryMay 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED DUE TO DISLOCATION FROM CONSTRAINED LINER. NEW LINER AND HEAD WERE PLACED. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 21971292 ↗InjuryMar 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT ON (B)(6) 2016 PATIENT UNDERWENT REVISION FOR DISLOCATION. AT SOME POINT, PATIENT WAS DISLOCATED AGAIN. REVISION TOOK PLACE ON (B)(6) 2025 WITHOUT INCIDENT A32+1 AND +4 NEUTRAL 32 X 52 CONSTRAINED LINER WAS USED. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 21634655 ↗InjuryFeb 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO DISLOCATION. SO, THE LINER WAS SWAPPED. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 21472769 ↗InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO INFECTED RIGHT THA. REMOVED THE CONSTRAINED LINER, TWO 5.0 PERIPHERAL SCREWS. REPLACED WITH A NEW CONSTRAINED LINER. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 19973802 ↗InjuryApr 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO SURGICAL DELAY IN THE CURRENT PROCEDURE. B. WAS THERE ANY ALLEGATION AGAINST THE SCREWS? NO ALLEGATIONS ABOUT THE SCREWS. C. WAS THERE ANY DISASSOCIATION REPORTED? THE RING WAS DISASSOCIATED. D. WAS THERE ANY ALLEGATION AGAINST THE CUP? NO ALLEGATIONS AGAINST THE CUP.
Patient problems: Joint Dislocation
MAUDE report 19117983 ↗InjuryJan 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT DISLOCATED CONSTRAINED LINER. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Insufficient Information
MAUDE report 18571329 ↗InjuryJan 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO HEAD BALL DISLOCATED THROUGH CONSTRAINED LINER. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Joint Dislocation
MAUDE report 18444919 ↗InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INFECTION, SURGEON REMOVED ALL IMPLANTS AND REPLACED WITH TEMPORARY ANTIBIOTIC SPACER ACTIVITY LEVEL - YES. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. (B)(6) AFFECTED SIDE: RIGHT
Patient problems: Unspecified Infection
MAUDE report 18284359 ↗InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INFECTION. THE PATIENT HAD IRRIGATION AND DEBRIDEMENT WITH POLY AND HEAD WAS EXCHANGED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE : RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 18172949 ↗InjurySep 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 17798294 ↗InjuryJul 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE : UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 17318844 ↗InjuryApr 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO DISLOCATION. THE SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 16833260 ↗InjuryApr 25, 2023Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated
THE PATIENT WAS REVISED DUE TO A FALL AND DISLOCATED CONSTRAINED LINER. THE CONSTRAINING RING BROKE IN TWO PIECES. THE PATIENT HAD A PREVIOUS ((B)(6)) PELVIC FRACTURE WITH PLATE AND SCREW FIXATION AND A TOTAL HIP. HEAD AND LINER EXCHANGE WAS PERFORMED. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.
Patient problems: Fall; Joint Dislocation
MAUDE report 16806923 ↗MalfunctionApr 25, 2023Fracture; Fracture
PATIENT WAS REVISED WITH HIP DISLOCATION AND WAS OUT FOR A WEEK SO THE LEG WAS VARY CONTRACTED. SURGEON FIRST STARTED BY REMOVING DUAL MOBILITY AND PUTTING IN A CONSTRAINED LINER TRIED TO REDUCE A 32 +5 HEAD BUT WITH THE LEG BEING CONTRACTED, IT WAS UNABLE TO GET THE HIP REDUCED , THEN TRIED A 32 +1 HEAD AND AFTER MANY ATTEMPTS. SURGEON FINALLY REDUCED THE HIP BUT CRACKED THE TOP OF THE CONSTRAINED LINER, AFTER 30 MINUTES OF REMOVING THE CONSTRAINED LINER SURGEON WENT WITH A 36 +4 10* LINER AND 36 +8.5 HEAD. DOI: (B)(6) 2022. DOR: UNKNOWN. AFFECTED SIDE: LEFT HIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16805999 ↗InjuryMar 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT FELL AND DISLOCATED HER HIP. SURGEON REPLACED HEAD BALL AND CONSTRAINED LINER. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.
Patient problems: Fall; Joint Dislocation
MAUDE report 16551725 ↗
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
- 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
- Trident 690-00-28GHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall11 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.