PINNACLE ALTRX 1221-32-052Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS ALTRX POLYETHYLENE ACETABULAR LINER NEUTRAL 32mm ID 52mm OD · Class 2 · Implant
Quick summary
This DePuy Pinnacle ALTRX hip liner is a hip replacement part that sits inside the cup. Many of the 124 reports describe the joint dislocating or the liner dislodging, and some describe infection or pain. The reports include no deaths and 122 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
- 125
- Deaths reported
- 0
- Injuries reported
- 123
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 125 adverse event reports that list this exact device (DI 10603295016113), received between Jul 21, 2017 and Sep 1, 2026 — classified as 123 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (63 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 Dislocated63
- Adverse Event Without Identified Device or Use Problem43
- Fracture10
- Naturally Worn7
- Disassembly5
- Insufficient Device Problem Information4
- Break2
- Separation Problem2
Patient problems
- Joint Dislocation40
- No Code Available34
- Pain28
- Unspecified Infection22
- Insufficient Information10
- Joint Laxity10
- Fall7
- Not Applicable7
Recent adverse event reports
The 25 most recent of 125 reports, in the reporter's own words as published by the FDA.
InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Pain
MAUDE report 50543088 ↗InjuryJun 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ENTIRE CONSTRUCT WAS REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED IN ITS POSITION. ALL PIECES WERE REMOVED FROM THE SURGICAL FIELD IMMEDIATELY AND THERE WAS NO HARM DONE TO THE PATIENT. AFFECTED SIDE- RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 25562353 ↗InjuryApr 28, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT A PATIENT WHO HAD A THA IN 2020 (CORAIL/PINNACLE) FALL 2 WEEKS AGA AND SUBLUXATED HIS ACETABULAR CUP INLAY.
Patient problems: Fall; Pain
MAUDE report 25012831 ↗InjuryFeb 26, 2026Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2026 AND 52 CUP; 32X52 LINER, 36MM HEAD WERE ALL IMPLANTED. POSTOPERATIVE REVIEW OF X-RAYS REVEALED THAT THE HEAD DID NOT APPEAR TO BE PROPERLY SEATED, AND IT WAS DETERMINED THROUGH THE IMPLANT LOG THAT AN INCORRECT HEAD HAD BEEN IMPLANTED. A REVISION SURGERY WAS PERFORMED TO REPLACE THE HEAD AND LINER WITH THE CORRECT SIZES. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 24457192 ↗InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS COMPLAINING ABOUT SOFT TISSUE IRRITATION AND DR. THOUGHT IT MIGHT BE DUE TO THE SCREW EXTENDING THROUGH BONE AND IN TO SOFT TISSUE. THEY DECIDED TO WASH OUT AND DO A HEAD AND LINER EXCHANGE WHICH HAS RESOLVED HER ISSUE. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.
Patient problems: Inflammation
MAUDE report 24431734 ↗InjuryFeb 20, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT ALTRX NEUT 32IDX52OD AND AN UNKNOWN HIP ACETABULAR CUP WERE ASSOCIATED WITH A REPORTED EVENT INVOLVING IMPLANT DISASSOCIATION. THE EVENT INVOLVED A PATIENT WHO EXPERIENCED LOOSENING OF THE INSERT MARATHON, UNDERWENT RE-OPERATION WITH ALTRX, AND SUBSEQUENTLY EXPERIENCED RECURRENT LOOSENING. THE EVENT WAS CODED FOR IMPLANT DISASSOCIATION AND INVOLVED A CORRECTIVE INVASIVE PROCEDURE IN WHICH A DEVICE WAS REPLACED OR REVISED.
Patient problems: Insufficient Information
MAUDE report 24401710 ↗InjuryDec 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT DISLOCATED POST OP. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 23844353 ↗InjuryDec 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT WAS DISLOCATING. SURGEON DETERMINED THAT THE PATIENTS CUP WAS MALPOSITIONED AND OPTED TO REVISE THE ACETABULUM. THE ORIGINAL CUP, LINER, AND 32 CERAMIC HEAD WERE REMOVED AND REPLACED WITH A REVISION CUP FROM ANOTHER MANUFACTURER. A TRIAL REDUCTION WAS PERFORMED WITH 40MM +12 HEAD AND THE HIP WAS STABLE. A 40MM +12 TS CERAMIC HEAD WAS OPENED AND IMPLANTED. STABILITY OF THE HIP WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. ACTIVITY LEVEL: YES. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 23730346 ↗InjuryNov 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT HIP HEAD WAS SUBLUXING OUT OF LINER FROM LOOSE JOINT. AFFECTED SIDE- RIGHT HIP.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 23632589 ↗InjuryNov 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO CHRONIC DISLOCATING, WENT FROM 32 52 PINNACLE LINER WITH 32 +1 HEAD TO CONSTRAINED LINER AND TS HEAD. NO DELAY IN CASE. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 23452864 ↗InjurySep 18, 2025Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO POLY DISSOCIATION AND POLY WEAR. DOI: ON (B)(6) 2020, DOR: ON (B)(6) 2025, AFFECTED SITE: RIGHT HIP.
Patient problems: Insufficient Information
MAUDE report 23085139 ↗InjuryAug 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT PRESENTED WITH A DISLOCATED LEFT TOTAL HIP REPLACEMENT. THE SURGEON ELECTED TO REMOVE THE ORIGINAL HEAD AND LINER CONSTRUCT AND REPLACE IT WITH A CONSTRAINED LINER CONSTRUCT WITH A LONGER FEMORAL HEAD IN AN EFFORT TO KEEP THE HIP LOCATED IN PLACE. DOI: ON (B)(6) 2023, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 22851034 ↗InjuryAug 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT FELL AND DISLOCATED, REVISED WITH A CONSTRAINED LINER. DOI: (B)(6) 2019. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.
Patient problems: Fall; Joint Dislocation
MAUDE report 22720322 ↗MalfunctionJul 17, 2025Fracture; Difficult to Insert; Fracture; Difficult to Insert
IT WAS REPORTED THAT THE LINER BROKE THE ARDS EDGES AND CAN NOT FIX INTO PINNACLE CUP. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. ANOTHER ONE WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22531343 ↗InjuryJun 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT STARTED TO EXPERIENCE ¿SQUEAKING¿ NOISES. NO INCIDENT OCCURRED. UPON X-RAY SURGEON FOUND POLY LINER UNENGAGED. LINER INCLUDED WAS REMOVED ONE SCREW AND 32+ 5 BIO CERAMIC HEAD. PATIENT REQUIRED A REVISION SURGERY.
Patient problems: Insufficient Information
MAUDE report 22331052 ↗InjuryMay 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT HAS DISLOCATED TWICE SINCE PRIMARY AS A RESULT OF DISREGARDING POST OP PROTOCOLS. COMPONENTS WERE WELL PLACED BUT PATIENT WAS NONCOMPLIANT. PATIENT WAS FIRST REDUCED WITHOUT COMING BACK TO THE OR. DOCTOR DECIDED TO REVISE STANDARD LINER TO A CONSTRAINED LINER. DOI:(B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 22055354 ↗InjuryMay 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
(B)(6) SCHOOL OF ENGINEERING AT (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: REVISION DUE TO RECURRENT DISLOCATIONS POST FALL. AT REMOVAL THE ACETABULAR LINER SHOWED MODERATE YELLOWING.
Patient problems: Joint Dislocation
MAUDE report 21979271 ↗InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO PAIN. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Pain
MAUDE report 21875489 ↗InjuryOct 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT WHILE THE PATIENT WAS GETTING INTO HER CAR WHEN SHE FELT AND HEARD A POP. THEN THE HIP STARTED SQUEAKING. THE POLY DISASSOCIATED WITH THE CUP. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.
Patient problems: Insufficient Information
MAUDE report 20531921 ↗InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT WASHOUT FOR INFECTION. ORIGINAL DATE OF SURGERY WAS (B)(6) 2016, RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 20531655 ↗InjuryOct 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO RECURRENT DISLOCATION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2012. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 20522415 ↗InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS SUFFERING FROM PAIN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.
Patient problems: Pain
MAUDE report 20516756 ↗InjuryOct 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO CHRONIC DISLOCATION. DOE: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 20351510 ↗InjurySep 30, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? THIS IS COUNTED AS AN ADDITIONAL SURGERY BECAUSE THEY DID NOT LEAVE THE ROOM AND THEN HAD TO GO BACK. B. WHAT SIDE WAS AFFECTED BY THIS EVENT? LEFT SIDE. D. IS THERE ANY ALLEGATION AGAINST THE CUP AND STEM? THERE IS NO ALLEGATION AGAINST THE CUP OR HEAD.
Patient problems: Joint Dislocation
MAUDE report 20332453 ↗InjuryAug 8, 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 PAIN. DOI:(B)(6) 2019. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.
Patient problems: Pain
MAUDE report 19942757 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.