PINNACLE ALTRX 1221-28-050Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS ALTRX POLYETHYLENE ACETABULAR LINER NEUTRAL 28mm 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 polyethylene liner is the plastic socket liner used in hip replacements. The 28 reports mostly describe the liner coming loose or dislocating from the cup, along with hip dislocation, and in several cases the liner separating from the head so the patient needed revision surgery. All 28 reports involve injuries, with 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
- 28
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10603295015956), received between Nov 20, 2017 and Jun 1, 2024 — classified as 28 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (23 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 Dislocated23
- Fracture2
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Disassembly1
- Naturally Worn1
- Separation Problem1
Patient problems
- Joint Dislocation18
- No Code Available10
- Insufficient Information3
- Not Applicable3
- Unspecified Infection3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Joint Laxity1
- No Information1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
InjuryJun 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT'S ACETABULAR LINER AND FEMORAL HEAD WERE REVISED DUE TO DISASSOCIATION. DOI: (B)(6) 2011; DOR: (B)(6) 2024; AFFECTED SIDE : LEFT HIP.
Patient problems: Insufficient Information
MAUDE report 19442736 ↗InjuryMar 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: DISLOCATION, INSTABILITY.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 18958741 ↗InjuryFeb 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO LINER DISASSOCIATION. DOI: (B)(6) 2021 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT HIP.
Patient problems: Insufficient Information
MAUDE report 18794323 ↗InjuryNov 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO DISSOCIATION OF LINER. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.
Patient problems: Insufficient Information
MAUDE report 18048774 ↗InjuryFeb 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT HAS DISLOCATED RECENTLY TWO TIMES IN THE LAST MONTH. THE SURGEON REVISED THE LINER FROM A 28 X 50 NEUTRAL LINER TO A 32 X 50 + 4 10 DEGREE LINER AND 32 + 5 BALL. PATIENT WAS VERY STABLE AND SURGEON WAS SATISFIED. THE LINER EXTRACTOR TIP BROKE OFF AND WAS RETRIEVED DURING EXTRACTION. DOI: (B)(6) 2016. DOR:(B)(6) 2022. UNK HIP.
Patient problems: Joint Dislocation
MAUDE report 13525147 ↗InjuryOct 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAS A HISTORY OF MULTIPLE DISLOCATIONS. ALL COMPONENTS WERE WELL FIXED. DR. B REMOVED THE HEAD, CUP, AND LINER. REVISED THE ACETABULUM TO A LARGER CUP AND USED DUAL MOBILITY. UNKNOWN HOSPITAL OR SURGEON. DOI: UNKNOWN. DOR: (B)(6) 2021. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 12721195 ↗InjurySep 30, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED AS POLY DISASSOCIATION FROM CUP. REVISED TO A DUAL MOBILITY CONSTRUCT. DOI: (B)(6) 2014. DOR: (B)(6) 2021. AFFECTED SIDE: RIGHT HIP.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Dislocation
MAUDE report 12554088 ↗InjuryNov 24, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED DUE TO LINER AND HEAD WERE DISLOCATED. PUT IN A CONSTRAINED LINER AND NEW HEAD. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 10898463 ↗InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED HIP. NO SURGICAL DELAY NOTED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, UNKNOWN AFFECTED SIDE.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 10685530 ↗InjuryAug 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE LINER WAS DISASSOCIATED DOI: (B)(6) 2019, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.
Patient problems: No Code Available
MAUDE report 10355961 ↗InjuryMar 30, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS LEFT HIP DISLOCATIONS- REMOVED NEW LINER AND IMPLANTED CONSTRAINED LINER WITH LOCKING RING. PATIENT HAD SOME SPINE ISSUES CAUSING NERVE AND MUSCLE WEAKNESS DOI: (B)(6) 2010. DOR: (B)(6) 2020. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation; No Code Available; Weakness
MAUDE report 9898272 ↗InjuryDec 5, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT DISLOCATED. ORIGINAL HIP WAS DONE IN (B)(6) ROUGHLY 15 YEARS PRIOR. SURGEON ELECTED TO GO TO A 32MM X 50MM 4/10 DEGREE LINER AND 32MM+5 BALL. DOI: UNKNOWN. DOR: (B)(6) 2019; RIGHT HIP.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 9415691 ↗InjuryNov 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED FOR DISLOCATION. DOI: (B)(6) 2019. DOR: UNKNOWN; LEFT HIP.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 9353800 ↗InjuryOct 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD DISLOCATED SO THE LINER WAS CHANGED TO CONSTRAINED. DOI: (B)(6) 2010; DOR: (B)(6) 2019; LEFT HIP.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 9186659 ↗InjuryAug 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES DISLOCATION WITH OPEN AND CLOSED REDUCTION. AFTER REVIEW OF MEDICAL RECORDS, CLINICAL VISIT REPORTED DISLOCATED LEFT HIP, ANTALGIC GAIT AND ABDUCTOR DEFICIENT GAIT. DOI: (B)(4)2012 - DOR: NONE REPORTED (LEFT HIP, SECOND REVISION). PLEASE SEE (B)(4) FOR THE FIRST REVISION.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 8932345 ↗InjuryApr 8, 2019Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated
IT WAS REPORTED THAT ACCORDING TO SURGEON, PATIENT WAS SQUATTING WHEN THE DISSOCIATION OF A PINNACLE LINER OCCURRED. CONFIRMED INTRA-OP 1 ARD WAS FLIPPED OUTWARD, 2 WERE COMPLETELY SHEARED OFF AND 1 WAS PARTIALLY SHEARED OFF. THE SURGEON DECIDED TO RETAIN THE 50MM SHELL BECAUSE HE FELT THERE WAS NO DAMAGE TO THE LOCKING MECHANISM. A 32X50 NEUTRAL LINER AND 32+1 TS CERAMIC HEAD WERE PLACED. DOI: (B)(6) 2011; DOR: (B)(6) 2019; RIGHT HIP.
Patient problems: No Code Available
MAUDE report 8491203 ↗InjuryNov 20, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
InjuryOct 23, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
SUBJECT ID: (B)(6). ASSOCIATED STUDY: ANTERIOR, GENERAL HIP--DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE IN SEVERITY. EVENT IS NOT RELATED TO DEVICE AND IS RELATED TO PROCEDURE. DOI: (B)(6) 2017; DOE: (B)(6) 2018; THIS EVENT IS CONSIDERED RESOLVED AS OF (B)(6) 2018; LEFT HIP. PATIENT UNDERWENT CLOSED REDUCTION/MANIPULATION AND PHYSICAL THERAPY FOR LEG STRENGTHENING.
Patient problems: Joint Dislocation
MAUDE report 7994526 ↗InjuryOct 10, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED ON (B)(6) 2016 FOR INFECTION OF LEFT TOTAL HIP ARTHROPLASTY (POST-REVISION ON (B)(6) 2008, WITH ORIGINAL DOI: (B)(6) 2007--SEE (B)(4)). ALL DEPUY PRODUCTS WERE EXPLANTED, AND ANTIBIOTIC SPACERS IMPLANTED FOR A TWO STAGE REVISION. DUE TO THE PERIOD OF TIME ELAPSED FROM THE LAST REVISION SURGERY TO THE CURRENT EVENT DATE, IT IS REASONABLE TO CONCLUDE THAT THE PREVIOUS SURGERY AND DEPUY PRODUCTS WERE NON-CONTRIBUTORY TO THE INFECTION, AND THEREFORE PRODUCTS ARE ADDED TO COMPLAINT AS MDR NO FOR REPORTABILITY. UPDATE 01 MAY 2018: PPF ALLEGES DISLOCATION AND LOOSENING OF STEM.
Patient problems: Joint Dislocation; No Code Available; Unspecified Infection
MAUDE report 7951324 ↗InjurySep 26, 2018Separation Problem; Separation Problem
IT WAS REPORTED THAT PATIENT PRESENTED WITH LEFT HIP PAIN AND GRINDING, THE PINNACLE LINER HAS SPONTANEOUSLY DISSOCIATED FROM THE PINNACLE SOCKET. A NEW HEAD AND LINER WERE PLACED.
Patient problems: Not Applicable; Pain
MAUDE report 7911178 ↗InjuryAug 22, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED TO ADDRESS RECURRENT DISLOCATION. LINER WAS CHANGED TO OFFSET, LIPPED LINER AND HEAD LENGTH WAS INCREASED. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 7806206 ↗InjuryMay 23, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT HIP. NO SURGICAL DELAY.
Patient problems: Joint Dislocation; Not Applicable
MAUDE report 7536788 ↗InjuryApr 4, 2018Fracture; Naturally Worn; Fracture; Naturally Worn
DER STATES THAT THE LINER RIM WAS CRACKED AND HEAD WAS WORN FROM METAL WEAR. IT WAS ALSO REPORTED THAT AFTER LINER WAS TAKEN OUT THE CUP WAS EVALUATED AND WEAR ON INSIDE OF CUP WAS NOTICED. DOI: (B)(6) 2013; DOR: (B)(6) 03, 2018; RIGHT HIP.
Patient problems: Not Applicable
MAUDE report 7395841 ↗InjuryFeb 8, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS DISLOCATION.
Patient problems: Joint Dislocation
MAUDE report 7250720 ↗InjuryJan 10, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
DER STATES THAT PATIENT S/P THA IN 2015 W/RECENT X2 DISLOCATIONS. SURGEON DECIDED TO REPLACE LINER TO A CONSTRAINED LINER TO HELP PREVENT FURTHER DISLOCATIONS. DOI: UNKNOWN; DOR: (B)(6) 2017; UNKNOWN HIP.
Patient problems: Joint Dislocation
MAUDE report 7177975 ↗
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