Skip to content

PINNACLE 1219-32-252Recalls & reported problems

Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS MARATHON POLYETHYLENE ACETABULAR LINER LIPPED 32mm ID 52mm OD · Class 2 · Implant

Quick summary

This DePuy Pinnacle hip liner is a plastic socket insert used in hip replacement. Reports mostly describe the liner slipping out of place leading to hip dislocation and instability, often needing repeat surgery, with some mentioning pain and infection. There are 26 reports naming its identifier, with no deaths and 26 injuries. 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
27
Deaths reported
0
Injuries reported
27
Recalls naming it
0

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295014188), received between Aug 11, 2017 and Sep 8, 2026 — classified as 27 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (16 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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device Dislodged or Dislocated16
  • Adverse Event Without Identified Device or Use Problem8
  • Fracture3
  • Noise, Audible3
  • Disassembly1
  • Insufficient Device Problem Information1
  • Naturally Worn1

Patient problems

  • Joint Dislocation14
  • No Code Available7
  • Pain6
  • Joint Laxity5
  • Unspecified Infection3
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
  • Discomfort2
  • Ambulation or Postural Difficulties1

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

  • InjurySep 8, 2026Device Dislodged or Dislocated

    It was reported that there was a Revision of Pinnacle 32/52 Lipped liner 121732252 390A15. Implanted due to dislocation. Cup was retained and converted to Pinnacle Dual Mobility.

    Patient problems: Joint Dislocation

    MAUDE report 50673824 ↗
  • InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT REVISION LEFT ACETABULUM DUE TO INSTABILITY. ORIGINAL DOS: (B)(6) 2023. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

    Patient problems: Joint Laxity

    MAUDE report 23887664 ↗
  • InjuryMay 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT THE LEFT HIP WAS REVISED BECAUSE IT DISLOCATED TWICE BEFORE. AFFECTED SIDE: LEFT HIP.

    Patient problems: Joint Dislocation

    MAUDE report 21942528 ↗
  • InjuryNov 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT THE PATIENT UNDERWENT THE HIP REVISION SURGERY DUE TO PAIN CAUSED BY THE INSERT SLIPPING OUT OF THE BEARING SHELL. DURING THE REVISION PROCEDURE, IT WAS FOUND THAT ADVANCED METALLOSIS WAS PRESENT IN THE JOINT. THE OPERATION WAS ENDED WITH A REVISION OF THE BEARING SHELLS, THE INSERTS AND THE REPLACEMENT OF THE HEAD ON THE FEMUR STEM.

    Patient problems: Foreign Body Reaction; Pain

    MAUDE report 20700398 ↗
  • InjuryOct 29, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED, THAT THERE WAS A REVISION OF PINNACLE LINER, DUE TO DISLOCATION ON A RIGHT THR. PATIENTS ORIGINAL SURGERY WAS DONE ON (B)(6) 2015. PATIENT HAD A FALL THIS YEAR AND SUSTAINED A PERIPROSTHETIC FRACTURE AND REQUIRED A REVISION OF THE STEM.

    Patient problems: Joint Dislocation

    MAUDE report 20557092 ↗
  • InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT EXPERIENCING PAIN 4 YEARS POST OP. NO REAL FINDINGS ON IMAGINING. CUP REMOVED TO REVIEW BEHIND THE SOCKET. AGAIN, NO FINDINGS BEHIND THE SOCKET OF SIGNIFICANCE.

    Patient problems: Pain

    MAUDE report 19991542 ↗
  • InjuryMay 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

    ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE AFFECTED SIDE WAS THE RIGHT HIP.

    Patient problems: Fall; Joint Dislocation

    MAUDE report 16844053 ↗
  • InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REVISED A CORAIL/ PINNACLE CONSTRUCT WHICH WAS IMPLANTED (B)(6) 2016. REVISION IS DUE TO SUSPECTED INFECTION PT REPORTS PAIN. DOI: (B)(6) 2016. DOR: (B)(6) 2023. UNKNOWN SIDE.

    Patient problems: Pain; Unspecified Infection

    MAUDE report 16537325 ↗
  • InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PINNACLE CUP REVISION DUE TO INSTABILITY. G7 DUAL MOBILITY PUT IN PLACE. DOI: UNKNOWN. DOR: (B)(6) 2022. LEFT HIP.

    Patient problems: Joint Laxity

    MAUDE report 15751145 ↗
  • InjuryFeb 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

    REVISION OF PINNACLE LIPPED LINER & HEAD DUE TO THE PATIENT HAVING REOCCURRING DISLOCATION ISSUES. LINER REMOVED WITH NO ISSUES, SURGEON MADE A COMMENT REGARDING A WARN SECTION ON THE POLY WHICH IS WERE THE HEAD WAS DISLOCATING OUT OF. NO OTHER ISSUES MENTIONED. THE LEFT HIP WAS OPERATED ON. PRIMARY SURGERY WAS DONE AT (B)(6) (DOES NOT EXISTED ANYMORE) IN 2015 BY THE SAME SURGEON. DOI: 2015, DOR: (B)(6) 2022, LEFT HIP.

    Patient problems: Joint Dislocation

    MAUDE report 13414852 ↗
  • InjuryDec 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT WAS REVISED DUE TO AN UNSTABLE HIP. THE SURGEON REMOVED THE LINER AND REPLACED WITH A DUAL MOBILITY PINNACLE SHELL AND BI-MENTUM HEAD. THE PATIENT'S HIP WAS STABLE UPON COMPLETION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2014, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

    Patient problems: Joint Laxity

    MAUDE report 13061429 ↗
  • InjuryDec 20, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

    THA REVISION COMPLETED SECONDARY TO INSTABILITY AND DISLOCATION. HEAD AND LINER WERE REMOVED AND A CONSTRAINED POLY AND METAL HEAD WERE IMPLANTED. LEFT HIP.

    Patient problems: Joint Dislocation; Joint Laxity

    MAUDE report 13043625 ↗
  • InjuryDec 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

    REVISION OF A CORAIL PINNACLE THA DUE TO DISLOCATION. THE PRIMARY SURGERY WAS DONE ON (B)(6) 2019. PATIENT WAS A (B)(6) YEAR OLD FEMALE, RIGHT SIDE. THIS WAS NOT A RESULT OF IMPLANT FAILURE. THE SURGEON NOTED THAT THE JOINT WAS VERY 'LAX' AS THERE WAS NOT ENOUGH OFFSET FROM THE STEM AND HEAD. THE PATIENT ALSO HAD 'FLAT BACK' POSTURE WHICH MAY HAVE ALSO ATTRIBUTED TO THE DISLOCATING. THE LIPPED LINER AND HEAD WERE EXPLANTED AND A DUAL MOBILITY LINER AND HEAD WERE IMPLANTED. THE STEM AND CUP WERE NOT REVISED AS THERE WAS NO ISSUE WITH THESE. DOI: (B)(6) 2019. DOR: (B)(6) 2021; RIGHT HIP.

    Patient problems: Joint Dislocation; Joint Laxity

    MAUDE report 12953235 ↗
  • InjuryAug 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    3 WEEK OLD THR SLIGHT WOUND BREAKDOWN. SWABS TAKEN BUT SPECIMEN WAS CONTAMINATED. SURGEON CHOSE TO DO A PROPHYLACTIC LINER AND HEAD CHANGE WITH FULL WASHOUT. REASON FOR REVISION WAS DUE TO INFECTION. PATIENT EXPERIENCE WOUND OOZING. PATIENT ALSO UNDERWENT A CT SCAN.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fluid Discharge; Wound Dehiscence

    MAUDE report 12306448 ↗
  • InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT REVISED TO TREAT INFECTION. DOI: (B)(6) 2021; DOR: (B)(6) 2021; UNKNOWN HIP.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 12211948 ↗
  • InjuryApr 12, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

    TODAY SURGEON PERFORMED A HIP HEAD AND LINER EXCHANGE ON PATIENT. OPERATIVE SIDE: RIGHT. REASON FOR REVISION: PATIENT REPORTED DISLOCATION DURING DAILY ACTIVITIES. THE SURGEON STATED INTRAOPERATIVELY THAT PATIENT REQUIRED AN INCREASE IN OFFSET. ORIGINAL SURGERY PERFORMED ON (B)(6) 2019.

    Patient problems: Joint Dislocation

    MAUDE report 11651528 ↗
  • InjuryNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE SURGEON DID A RIGHT WASHOUT, DEBRIDEMENT AND POLY AND HEAD EXCHANGE ON PATIENT FOR INFECTION. THE ORIGINAL RIGHT TOTAL HIP REPLACEMENT WAS ON (B)(6) 2020.

    Patient problems: No Code Available; Unspecified Infection

    MAUDE report 10813081 ↗
  • InjuryAug 6, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

    PT HAD PRIMARY HIP REPLACEMENT ON (B)(6) 2020. PT DISLOCATED DAY 1 POST OP. SURGEON REVISED HIP FOR INSTABILITY- CHANGING THE LINER, HEAD, STEM AND IMPLANTED AN ADDITION SCREW IN THE ACETABULAR CUP. RIGHT HIP.

    Patient problems: Joint Dislocation; No Code Available

    MAUDE report 10373285 ↗
  • InjuryFeb 24, 2020Fracture; Device Dislodged or Dislocated; Noise, Audible; Fracture; Device Dislodged or Dislocated; Noise, Audible

    REVISION OF ACETABULAR COMPONENTS OF HIP-TEP UNKNOWN SIDE BECAUSE OF DISASSOCIATION OF CUP AND INLAY.

    Patient problems: Discomfort; No Code Available

    MAUDE report 9746483 ↗
  • InjuryFeb 18, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

    REVISION TOTAL HIP REPLACEMENT FOR INSTABILITY AND DISLOCATION HEAD AND LINER CHANGE. LINER CHANGED TO A CONSTRAINED LINER WITH SUBSEQUENT FEMORAL HEAD EXCHANGE.

    Patient problems: Joint Dislocation; No Code Available

    MAUDE report 9722494 ↗
  • InjuryNov 18, 2019Fracture; Device Dislodged or Dislocated; Naturally Worn; Noise, Audible; Fracture; Device Dislodged or Dislocated; Naturally Worn; Noise, Audible

    AFTER REVISION SURGERY PERFORMED ON (B)(6) 2019, PATIENT WENT TO HOSPITAL AND DEVICE IS BROKEN. PATIENT WILL NEED TO PERFOM ANOTHER SURGERY. THIS COMPLAINT IS RELATED WITH (B)(4).

    Patient problems: Discomfort; Joint Dislocation; No Code Available

    MAUDE report 9336785 ↗
  • InjuryJul 9, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

    PPF AND STICKER SHEETS RECORD RECEIVED. PPF ALLEGES INFECTION, COMPONENT FRACTURE AND DISLOCATION WITH CLOSED REDUCTION AFTER FIRST REVISION. DOI: (B)(6) 2007 (STEM, CUP AND HOLE ELIMINATOR). DOI: (B)(6) 2008 (HEAD AND LINER). DOR: (B)(6) 2012 (RIGHT HIP).

    Patient problems: Joint Dislocation; No Code Available; Unspecified Infection

    MAUDE report 8771403 ↗
  • InjuryNov 24, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

    REASON FOR REVISION: TWO EPISODES OF INSTABILITY/DISLOCATION OF HIP JOINT. SURGEON CHANGED ACETABULAR LINER AND FEMORAL HEAD TO ADDRESS INSTABILITY.

    Patient problems: Joint Dislocation; No Code Available

    MAUDE report 7057961 ↗
  • InjuryOct 13, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

    THE PATIENT WAS REVISED TO ADDRESS CONSTANT DISLOCATION. IT WAS STATED THAT A 32 LIPPED LINER WAS REMOVED ALONG WITH A 32 + 13 METAL HEAD BALL. A NEW CONSTRAINED LINER AND +9 CERAMIC WAS PUT BACK IN.

    Patient problems: Joint Dislocation

    MAUDE report 6949211 ↗
  • InjurySep 22, 2017Disassembly; Fracture; Disassembly; Fracture

    DER STATES THAT THE PATIENT HAD RIGHT PRIMARY HIP ON (B)(6) 2015. AT THAT TIME A 52MM PINNACLE SECTOR II CUP WAS IMPLANTED WITH X2 30MM SCREWS, A MARATHON 32X52 LIPPED LINER, +1 32 DELTA HEAD AND SZ 5 SUMMIT STD STEM. ON (B)(6) 2017 PATIENT RETURNED TO OR. FOLLOWING 6 MONTHS OF PAIN IN SAME HIP. PATIENT SUFFERED NO DISLOCATION. HIP OPENED AND LINER FOUND TO BE DISASSOCIATED FROM THE SHELL. LINER REMOVED,X2 SCREWS REMOVED AND NEW LINER (ALTRX +4/10 32ID) + DELTA BALL IMPLANTED.

    Patient problems: Pain

    MAUDE report 6885934 ↗

Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices

All PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.