PINNACLE ALTRX 1221-32-054Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS ALTRX POLYETHYLENE ACETABULAR LINER NEUTRAL 32mm ID 54mm OD · Class 2 · Implant
All models of PINNACLE ALTRX (98)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Pinnacle Altrx polyethylene liner is the plastic socket liner used in hip replacement surgery. Most of the 69 reports describe the liner coming loose or dislocating from its metal shell, along with hip pain and repeat revision operations; some mention the liner separating into pieces. There are 67 injuries and no deaths, and 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
- 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 10603295016120), received between Jun 30, 2017 and Sep 21, 2026 — classified as 68 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (35 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 Dislocated35
- Adverse Event Without Identified Device or Use Problem23
- Disassembly6
- Insufficient Device Problem Information5
- Naturally Worn2
- Appropriate Device Problem Term/Code Not Available1
- Device-Device Incompatibility1
- Fitting Problem1
Patient problems
- Joint Dislocation29
- No Code Available21
- Pain17
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
- Not Applicable5
- No Consequences Or Impact To Patient4
- Insufficient Information3
- Unspecified Infection3
Recent adverse event reports
The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Pain
MAUDE report 50848223 ↗InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PAIN OCCURED 1217. DOI- (B)(6) 2020, DOR- (B)(6) 2026, AFFECTED SIDE-LEFT HIP.
Patient problems: Pain
MAUDE report 25148060 ↗InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.
Patient problems: Pain
MAUDE report 23833406 ↗InjuryAug 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION DUE TO CHRONIC DISLOCATIONS. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 22796716 ↗InjuryAug 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD LEFT TOTAL HIP REPLACEMENT. PATIENT PRESENTED AS DISLOCATED SEVEN YEARS AFTER THE PRIMARY SURGERY. THE ATTENDING SURGEON ELECTED TO REMOVE THE STANDARD POLYETHYLENE LINER AND REPLACE IT WITH A CONSTRAINED LINER CONSTRUCT. THE FEMORAL HEAD WAS ALSO EXCHANGED AT THE SAME TIME. DOI: (B)(6) 2018. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 22730951 ↗InjuryFeb 10, 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 PAIN. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Pain
MAUDE report 21345793 ↗InjuryJan 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS DISLOCATED DUE TO TRAUMA. PINNACLE LINER AND BIOLOX HEAD WERE CHANGED FOR DUAL MOBILITY CONSTRUCT. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 21285069 ↗InjuryJan 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? -NO, THE SURGERY WAS THE RESULT OF THE DISLOCATION. B. WAS THERE ANY PATIENT HARM RELEVANT TO THIS EVENT? IF YES, PLEASE KINDLY PROVIDE DETAILS. -NO, OTHER THAN THEIR HIP LINER DISLOCATING FROM THE PINNACLE SHELL.
Patient problems: Joint Dislocation
MAUDE report 21282293 ↗InjuryJan 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION RECEIVED STATES THAT THE FIRST DISLOCATION INVOLVED DEPUY SYNTHES PRODUCTS (CORAIL STEM, BIOLOX CERAMIC HEAD, AND PINNACLE SHELL/LINER). THERE WAS AN ADVERSE CONSEQUENCE, THE HIP WAS DISLOCATED. THERE WAS NO SURGICAL DELAY, THE DISLOCATION HAPPENED DURING POST-OP.
Patient problems: Insufficient Information
MAUDE report 21178496 ↗InjuryNov 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT AFTER PATIENT'S INITIAL SURGERY, THEY HAVE DISLOCATED MULTIPLE TIMES. PATIENT HAS DEMENTIA AND UNABLE TO FOLLOW PROTOCOL (NONCOMPLIANT). SURGEON DECIDED TO WOULD REMOVE THE HEAD AND LINER AND SWITCH TO A CONSTRAINED LINER TO HOPEFULLY PREVENT THE PATIENT FROM FURTHER COMPLICATIONS. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 20676158 ↗InjuryMay 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACETABULUM LINER COMPONENT REVISION DUE TO ORIGINAL LINER DISPLACEMENT. ORIGINAL HIP REPLACEMENT OPERATION TOOK PLACE (B)(6) 2023. REVISION TOOK PLACE (B)(6) 2024.
Patient problems: Insufficient Information
MAUDE report 19250423 ↗InjuryApr 24, 2024Naturally Worn; Naturally Worn
A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: PAIN AND SUBSIDENCE OF A COMPETITOR FEMORAL STEM. AT REVISION THERE WAS MINOR YELLOWING OF THE ACETABULAR LINER. THERE WAS FRETTING OF THE COMPETITOR FEMORAL HEAD
Patient problems: Pain
MAUDE report 19173503 ↗InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INFECTION, LINER AND HEAD WERE CHANGED WITH A I&D. DOI: UNKNOWN. DOR: (B)(6) 2023 AFFECTED SIDE : LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 18129996 ↗InjuryMay 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY.
Patient problems: Joint Dislocation
MAUDE report 16940652 ↗InjuryApr 27, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO DISLOCATION OF HIS HIP SHORTLY AFTER SURGERY ON (B)(6). IT WAS DETERMINED THAT THE STEM ROTATED AFTER SURGERY. LOOSENING OF THE FEMORAL STEM WAS REPORTED AT BONE TO IMPLANT INTERFACE. DOI: ON (B)(6) 2023, DOR: ON (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 16823812 ↗InjuryDec 21, 2022Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
REVISION OF PINNACLE LINER AND HEAD. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? UNKNOWN. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?--> INFLAMATION AND DISCOMFORT. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC. REVISION) REQUIRED: YES. IF YES, DESCRIBE: PRE OP XRAYS. IS THE PATIENT PART OF A CLINICAL STUDY: NO. IP-01605784: DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. IP-01605785: DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.
Patient problems: Discomfort; Inflammation; Joint Dislocation
MAUDE report 16022804 ↗InjuryMay 23, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
REVISION COMPLETED DUE TO CHRONIC DISLOCATION. LINER AND HEAD WAS REPLACED WITH CONSTRAINED LINER AND METAL HEAD. NO SURGICAL DELAY. DOI: (B)(6) 2011. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 14468882 ↗InjurySep 28, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT OPERATED 2017 (B)(6) CLINIC. REOPERATED DUE TO LINER DISASSOCIATION. DOI: 2017, DOR: UNKNOWN, UNKNOWN SIDE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 12539767 ↗InjurySep 22, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
LINER DISASSOCIATION. OP (B)(6) 2020 (B)(6) HOSPITAL, (B)(6). REOPERATION DANDERYDS SJUKHUS, LINER WAS TOTALLY LOOSE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12516132 ↗InjurySep 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE LINER SWAPPED TO 36MM FOR STABILITY. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Joint Laxity
MAUDE report 12452408 ↗InjuryAug 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2018 - DOR: (B)(6) 2021 (RIGHT HIP).
Patient problems: Pain
MAUDE report 12277914 ↗InjuryJul 14, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT EXPERIENCED MULTIPLE DISLOCATIONS. NO FALLS OR TRAUMA. NO RELATIVE COMORBIDITIES. CUP IS IN GOOD POSITION. REPLACED HEAD AND LINER WITH PINNACLE DUAL MOBILITY. DOI: (B)(6) 2019 DOR: (B)(6) 2021 RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 12166117 ↗InjuryJun 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2018. DOR: (B)(6) 2021. AFFECTED SIDE: LEFT HIP.
Patient problems: Pain
MAUDE report 12028150 ↗InjuryMay 11, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE POLY DISASSOCIATED FROM THE CUP. INSERTED A NEW POLY WITH NO ISSUES WITH LOCKING MECHANISM. POLY WAS LOCKED AND STABLE. DOI: (B)(6) 2010. DOR: (B0(6) 2021. RIGHT HIP.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11805370 ↗InjuryApr 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED DUE TO LINER DISASSOCIATION. MAYBE FROM LIFTING WEIGHTS. NO OTHER INFO PROVIDED. DOI: (B)(6) 2015, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11634135 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 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.
How reports and recalls are matched · Editorial policy · Report an error on this page