PINNACLE ALTRX 1221-32-150Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS ALTRX POLYETHYLENE ACETABULAR LINER +4 10 DEGREES 32mm ID 50mm 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 is a plastic liner placed in the hip socket during total hip replacement. Its 239 reports mostly describe the liner dislodging or the hip dislocating, and some describe infection or pain. The reports include 237 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
- 240
- Deaths reported
- 0
- Injuries reported
- 238
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 240 adverse event reports that list this exact device (DI 10603295016168), received between Jul 12, 2017 and Sep 21, 2026 — classified as 238 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (145 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 Dislocated145
- Adverse Event Without Identified Device or Use Problem58
- Fracture17
- Naturally Worn15
- Insufficient Device Problem Information12
- Disassembly7
- Appropriate Device Problem Term/Code Not Available4
- Noise, Audible3
Patient problems
- Joint Dislocation122
- No Code Available71
- Pain35
- Unspecified Infection31
- Joint Laxity20
- Insufficient Information18
- Not Applicable13
- Tissue Damage8
Recent adverse event reports
The 25 most recent of 240 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Device Dislodged or Dislocated
Patient problems: Joint Dislocation
MAUDE report 50847991 ↗InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Cup, liner, screw and head were exchanged due to infection. There was no harm done to the patient and there was no adverse effects from the case. All pieces were removed from the field immediately. It was stated that Acetabular cup was loose. Loosening interface was marked as the bone to implant. DOI: UnknownDOR: (b)(6) 2026Affected side: Left.
Patient problems: Unspecified Infection
MAUDE report 50586245 ↗InjuryFeb 24, 2026Device Dislodged or Dislocated; Naturally Worn
IT WAS REPORTED THAT THE PATIENT PRESENTED IN DOCTOR CLINIC COMPLAINING OF "SQUEAKING" AFTER A LATE (B)(6) 2026 FALL ON HER RIGHT HIP. DOCTOR ELECTED TO REVISE FOR POSSIBLE LOOSE LINER. ON (B)(6) 2026 AT (B)(6) HOSPITAL DOCTOR REVISED THE PATIENTS RIGHT HIP. UPON EXPOSURE TO THE JOINT SPACE THE 32+1 DELTA CERAMIC HEAD WAS FOUND TO HAVE WEAR SUPERIORLY AS A RESULT OF ARTICULATION WITH THE PINNACLE SZ 50 SHELL. THE 50/32 10 DEGREE ALTRX LINER WAS NOT CORRECTLY POSITIONED IN THE ACETABULAR SHELL AND SHOWED SIGNS OF ABNORMAL WEAR. DOCTOR ELECTED TO PUT IN A NEW LINER AND REVISION CERAMIC HEAD THAT MET HIS CRITERIA AND CLOSED THE JOINT SPACE. NO INSTRUMENTS BROKE OR WERE LOST DURING THE CASE. THERE WAS NO SUGGESTION THAT THE PRODUCTS HAD NOT PERFORMED AS THEY HAD EXPECTED TO.
Patient problems: Fall
MAUDE report 24426512 ↗InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INSTABILITY. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Joint Laxity
MAUDE report 24266073 ↗InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE-RIGHT HIP.
Patient problems: Joint Laxity
MAUDE report 24261997 ↗InjuryJan 22, 2026Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO DISLOCATING. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 24146040 ↗InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SIGNS OF POSSIBLE INFECTION, DOCTOR DECIDED TO DO AN I&D AND SWAPPED THE POLY SINCE THE JOINT WAS OPENED FOR THE WASH OUT. AFFECTED SIDE: LEFT KNEE.
Patient problems: Unspecified Infection
MAUDE report 24115419 ↗InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS REVISED FOR PAIN. AFFECTED SIDE: UNKNOWN.
Patient problems: Pain
MAUDE report 24114961 ↗InjuryJan 6, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT THA WITH PINNACLE AND C-STEM AMT IN QUESTION ON AN UNKNOWN DATE. PRIMARY SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE PATIENT EXPERIENCED LOOSENING OF ARTIFICIAL HIP JOINT AND GLUTEAL HIP DISLOCATION, AND PENETRATION OF THE ACETABULAR SIDE OF THE PRODUCT INTO THE INNER PLATE. THE SECOND SURGERY WAS PERFORMED ON (B)(6) 2024. DURING REMOVAL, THE CUP, SCREW, AND LINER WERE REMOVED AS A SINGLE UNIT, AND THE TIP OF THE SCREW BROKE OFF AND REMAINED INSIDE THE BODY. HOWEVER, THE SURGEON DECIDED THAT IT WOULD BE DIFFICULT TO REMOVE, SO HE LEFT THE BROKEN TIP IN PLACE. ((B)(4) WAS NEWLY CREATED TO CAPTURE THE EVENT F BROKEN SCREW TIP) THE HEAD WAS REPLACED WITH A DELTATS36+12, AND THE SURGERY WAS COMPLETED. THE SURGEON COMMENTED THAT THE CUP PLACEMENT ANGLE DURING THE PRIMARY SURGERY WAS POOR.
Patient problems: Joint Dislocation
MAUDE report 23975715 ↗InjuryDec 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE LINER THE CAME LOOSE FROM CUP AND REVISION WAS DONE TO FIX IT. THE LINER AND HEAD WERE REPLACED. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Insufficient Information
MAUDE report 23783031 ↗InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DOCTOR BROUGHT THE PATIENT TO THE OR FOR HEAD AND POLY EXCHANGE. CULTURES WERE TAKEN TO DISCOVER IF INFECTION WAS PRESENT, UNKNOWN DATE OF IMPLANT, NO ADDITIONAL INFORMATION PROVIDED FOR REPORTING. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 23717029 ↗InjuryOct 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED TO CONSTRAINED LINER DUE TO RECURRENT DISLOCATIONS. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 23368668 ↗InjurySep 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO MULTIPLE DISLOCATIONS. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 23074573 ↗InjurySep 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS DISLOCATING ANTERIOR. THE SURGEON REMOVED THE HEAD AND POLY THEN TRIALED THE +4 10DEG PINNACLE POLY TRIAL WITH THE LIP ANTERIOR. RANGE OF MOTION WAS PERFORMED TO MAKE SURE THERE WAS NO IMPINGEMENT AND HIP WAS STABLE. THE SURGEON WAS HAPPY AND IMPLANTED NEW POLY LINER AND FEMORAL HEAD. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 22955843 ↗InjuryJul 28, 2025Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT A PRIMARY THR USING PINNACLE CORAIL ROUGHLY 12 MONTHS AGO. REVISION OF POLY AND FEMORAL HEAD OCCURRED POSTOPERATIVELY. THE LINER WAS FRACTURED. IMPLANTS WERE REPLACED WITH SIZE 50 OD 32 ID NEUTRAL ALTRX LINER, 32 + 9 CERAMIC DELTA TS HEAD.
Patient problems: Insufficient Information
MAUDE report 22628724 ↗InjuryJun 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PINNACLE LINER WAS DISSOCIATED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. DOI: (B)(6) 2020, DOR: (B)(6) 2025, AFFECTED AREA: RIGHT HIP.
Patient problems: Insufficient Information
MAUDE report 22155334 ↗InjuryMay 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD HER HIP REPLACED SOMETIME IN 2023 WHERE SHE RECEIVED A SUMMIT PINNACLE. AS A RESULT OF A FALL AND AN INJURY, THE PATIENT BEGAN TO HAVE DISLOCATION ISSUES OVER THE YEAR. DOCTOR DECIDED TO REVISE THE PATIENT¿S HIP, WHERE HE EXPLANTED THE ACETABULAR CUP, AND IMPLANTED ANOTHER CUP WITH A DUAL MOBILITY LINER TO STABILIZE HER HIP JOINT. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 22089915 ↗InjuryMay 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
"THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. DARTHMOUTH 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 DISLOCATION AND INSTABILITY. AT REVISION THE FEMORAL HEAD HAD CORROSION. THE ACETABULAR LINER SHOWED NECK IMPINGEMENT.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 21981516 ↗InjuryApr 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DUE TO REOCCURRING DISLOCATION, THE HEAD/LINER WERE EXCHANGED FOR CONSTRAINED LINER AND HEAD. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 21908161 ↗InjuryApr 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT HAD A HIP DONE IN 2016 AND HAD BEEN DOING WELL UNTIL A COUPLE MONTHS AGO. PATIENT HAS A LARGE LUMBER FUSION. PATIENT HAS DISLOCATED A COUPLE TIMES OVER THE PAST COUPLE MONTHS. THE DOCTOR DECIDED TO CHANGE THE LINER TO A CONSTRAINED LINER AND INCREASED NECK LENGTH FROM +1 TO +5. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 21873179 ↗InjuryFeb 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO DISLOCATION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 21448277 ↗InjuryJan 27, 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 INSTABILITY. AFFECTED SIDE: UNKNOWN.
Patient problems: Joint Laxity
MAUDE report 21242882 ↗InjuryJan 16, 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. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Pain
MAUDE report 21170713 ↗InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT WAS REVISED DUE TO INSTABILITY. THE SURGEON REMOVED THE PROXIMAL BODY, HEAD AND LINER AND IMPLANTED NEW IMPLANTS. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Joint Laxity
MAUDE report 21054746 ↗InjuryDec 26, 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 PAINFUL HIP AND PATIENT FELT SHORT. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2019. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Pain; Physical Asymmetry
MAUDE report 21019170 ↗
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