PINNACLE ALTRX 1221-36-158Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 10603295016434), received between Aug 8, 2017 and Jan 29, 2026 — classified as 63 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (38 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LINER & HEAD WERE REMOVED DUE TO INFECTION. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 24215239 ↗
• InjuryFeb 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2021, THE PATIENT HAD A RIGHT HIP IMPLANTED WITH DEPUY PRODUCTS. THE PRODUCTS IMPLANTED WERE: HOLE ELIMINATOR: 124603000, LOT: D21022056 PIN ALTRX LINER: REF: 122136158, LOT: J78Z44, CUP: 121703058, LOT: J5415K, STEM 157002135, LOT: 9623753, HEAD: 136551000, LOT:8650632. THE PATIENT WAS REVISED ABOUT 2 YEARS AGO (DATE NOT REMEMBERED) DUE TO MULTIPLE DISLOCATIONS WITH EXTREME PAIN. THE PATIENT STATED THAT HE DID NOT THINK ANY COMPONENTS WERE REMOVED BUT THAT THEY ADDED A "RING". PRIOR TO THAT SURGERY, THE PATIENT DID HAVE TO HAVE HIS CLOSED REDUCTIONS. NO RECALLS ARE INVOLVED. PATIENT IS LOOKING TO GET A REVISION SURGERY BUT NOTHING HAS BEEN SCHEDULED. DOI: (B)(6) 2021, DOR: UNKNOWN, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; Numbness; Pain

  MAUDE report 21471830 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HEAD AND LINER WAS EXCHANGED DUE TO SUBLUXATION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 21140193 ↗
• InjurySep 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SURGEON REPLACED LINER AND HEAD DUE TO DISLOCATION. COMPONENTS APPEAR TO BE WELL POSITIONED BUT PATIENT HAS BACK ISSUES WHICH APPEARS TO CONTRIBUTE TO THE DISLOCATIONS. ALL DEPUY IMPLANTS REMOVED APPEAR TO BE IN GOOD WORKING CONDITION. THE SURGEON TRIALED A DUAL MOBILITY CONSTRUCT AND CONSIDERED AN ESC LINER BUT THOUGHT THE BEST OPTION WAS TO USE A LINER WITH A 40MM HEAD. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 20136878 ↗
• InjuryJun 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED AND A REVISION TO DUAL MOBILITY WAS PERFORMED. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 19459705 ↗
• InjuryMay 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN AND DISLOCATION. DOI: (B)(6) 2020 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT HIP

  Patient problems: Joint Dislocation; Pain

  MAUDE report 19277916 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LINER AND HEAD WERE REMOVED AND REPLACED FOR IRRIGATION AND DEBRIDEMENT. SURGICAL DELAY UNKNOWN. US-FDA MDR REPORTABILITY DETERMINATION: HEAD AND LINER WERE REVISED TO PERFORM AN I&D WASHOUT. ALTHOUGH CLEAR ALLEGATIONS WERE NOT PROVIDED, IT IS REASONABLE TO CONCLUDE THAT THE HIP WAS REVISED TO ADDRESS A SERIOUS INJURY, WHETHER FOR INFECTION OR FOR A HEMATOMA, OR SOME SUCH TISSUE RELATED EVENT. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 18442517 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO SEPSIS. THE HEAD AND LINER WERE REMOVED, IRRIGATION AND DEBRIDEMENT (I&D) WAS PERFORMED, AND A NEW HEAD AND LINER WERE IMPLANTED. NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Sepsis

  MAUDE report 18230760 ↗
• InjuryAug 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ASR MEDICAL RECORDS RECEIVED. MEDICAL RECORD REPORTS REVISION SURGERY THAT LED TO DISLOCATION. DOI: (B)(6) 2022; DOR: UNKNOWN, RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17573979 ↗
• InjuryAug 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT LINER AND HEAD WERE REVISED FOR CHRONIC DISLOCATION. DOI: (B)(6) 2021. 1ST DOE: (B)(6) 2022. 2ND DOE: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17563956 ↗
• InjuryJan 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION COMPLETED DUE TO DISLOCATION. HAS A HISTORY OF ALCOHOLISM. AFTER MAKING INCISION, APPEARED ABDUCTORS WERE TORN OFF. FOR THIS REASON, A CONSTRAINED LINER WAS IMPLANTED ALONG WITH A LONGER NECK. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; Unspecified Tissue Injury

  MAUDE report 16103573 ↗
• InjurySep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT PRIMARY RIGHT TOTAL HIP REPLACEMENT SURGERY ON (B)(6) 2022. THE PATIENT PRESENTED BACK TO SURGEON FOR AN UNKNOWN REASON. THE PATIENT UNDERWENT A REVISION PROCEDURE ON THEIR RIGHT HIP ON (B)(6) 2022 WHERE ONLY THEIR CERAMIC HEAD AND ALTRX LINER WERE REVISED. THE PATIENT'S PRIMARY CUP, STEM AND SLEEVE WERE LEFT IN SITU. DOI: (B)(6) 2022, DOR: (B)(6) 2022, RIGHT HIP. ADDITIONAL INFORMATION: REVISION COMPLETED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 15484010 ↗
• InjurySep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT IS INFECTED AND WE ARE EXPLANTING COMPONENTS AND PUTTING IN A CEMENT SPACER. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15483930 ↗
• InjuryAug 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATING. SURGEON REMOVED ACTIS STEM AND PUT IN STRYKER RES MOD WITH OUR CONSTRAINED LINER. THERE WAS NO LOOSENING AND SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 15310923 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT IS INFECTED. DOING A WASH OUT POLY AND HEAD EXCHANGE. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14985862 ↗
• InjuryJun 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POLY LINER AND CERAMIC HEAD REVISED FOR INFECTION. SURGEON REMOVED EXISTING COMPONENTS AND IMPLANTED DUPLICATE REPLACEMENTS. HOSPITAL DISPOSED OF REMOVED IMPLANTS.

  Patient problems: Unspecified Infection

  MAUDE report 14845918 ↗
• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DEVELOPED AN INFECTION. A RESECTION ARTHROPLASTY WAS PERFORMED FOR INSERTION OF ANTIBIOTIC SPACER. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, UNKNOWN SIDE.

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

  MAUDE report 12480540 ↗
• InjuryMay 14, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S HIP HAS DISLOCATED MULTIPLE TIMES. DOI: (B)(6) 2018 DOR: (B)(6) 2021 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 11828734 ↗
• InjuryApr 28, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISLOCATION. A HEAD LINER EXCHANGE WAS PERFORMED. DOI: (B)(6) 2020; DOR: (B)(6) 2021; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 11737433 ↗
• InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2020, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 11342898 ↗
• InjuryJan 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT REVISED DUE TO DISLOCATION. REVISION TO A CONSTRAINED LINER. NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 11131623 ↗
• InjuryDec 16, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PCF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED FOR UNSTABLE LEFT THR DUE TO A COMBINATION OF SOFT TISSUE/MUSCULAR DAMAGE FROM PREVIOUS METALLOSIS, POSTERIOR IMPINGEMENT ON THE HOODED POLYETHYLENE INSERT, AND EXCESSIVE ANTEVERSION AND VERTICALITY OF HIS ACETABULAR CUP THAT HAD BEEN IMPLANTED IN 2005. THE PATIENT ALSO DEVELOP ANTERIOR RECURRENT DISLOCATION. OPERATIVE NOTES REPORTED THAT THERE WERE NO EXTERNAL ROTATOR OR POSTERIOR CAPSULE PRESENT DUE TO PREVIOUS SOFT DAMAGE ASSOCIATED WITH HIS METALLOSIS. THE PATIENT WAS IMPINGING POSTERIORLY VIA THE POSTERIOR GREATER TROCHANTER ON THE 10 DEGREE HOOD POLY INSERT. POSITIONING OF THE CUP WAS CONFIRMED TO BE SLIGHTLY VERTICAL AND ANTEVERTED FROM IDEAL. DOI: (B)(6) 2005 (CUP), DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: Joint Dislocation; Joint Laxity; Unspecified Tissue Injury

  MAUDE report 11020282 ↗
• InjuryOct 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEPUY HIP IMPLANTS WERE EXTRACTED DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10733308 ↗
• InjurySep 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I AND D WAS PERFORMED DUE TO HEMATOMA. HEAD AND LINER WAS REVISED. PATIENT ALLEGES PAIN, LOSS OF FUNCTION AND GENERAL DEBILITATION OF QUALITY OF LIFE, AND EMOTIONAL DISTRESS. DOI: (B)(6) 2015. DOR: (B)(6) 2015; RIGHT HIP.

  Patient problems: Hematoma; No Code Available; Pain

  MAUDE report 10540535 ↗
• InjurySep 2, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A TRAUMATIC EVENT 3 WEEKS POST-OP AND DISLOCATED. TAKEN TO OR TO THE REVISED LINER. DOI: (B)(6) 2020, DOR: (B)(6) 2020, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10483128 ↗