PINNACLE ALTRX 1221-28-048Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295015949), received between Sep 5, 2017 and Jan 29, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 14 most recent of 14 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 THE PATIENT WAS REVISED DUE TO STABILITY. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 24215882 ↗
• InjuryApr 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO LINER DISASSOCIATION, POSSIBLY BECAUSE OF A PROUD SCREW. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6), 2018. DOR: (B)(6), 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 19018082 ↗
• InjuryMar 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: INSTABILITY AND DISLOCATION.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 18960542 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO IMPINGEMENT. DOI: (B)(6) 2013. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 17869178 ↗
• InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO THE PAIN. DOI: UNK. DOR: (B)(6) 2022. AFFECTED SIDE: UNK.

  Patient problems: Pain

  MAUDE report 13636080 ↗
• InjurySep 8, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED TO DUE TO DISLOCATION. DOI: (B)(6) 2019, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10505512 ↗
• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED PERIPROSTHETIC LEFT HIP FRACTURE. OPERATIVES NOTES INDICATED SUBCUTANEOUS HEMATOMA, A SIGNIFICANT ROTATION OF THE FEMORAL STEM AND MOBILIZED FRACTURE FRAGMENT. DOI: (B)(6) 2018 DOR: (B)(6) 2018 LEFT HIP.

  Patient problems: Hematoma; No Code Available; Pain

  MAUDE report 9861037 ↗
• InjuryJan 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN AND INFECTION. ANTIBIOTIC SPACERS WERE THEN IMPLANTED. RE-REVISION TO REMOVED THE SPACERS AND RE-IMPLANTATION OF DEFINITE IMPLANTS OCCURRED ON (B)(6) 2011. DOI: (B)(6) 2008 (CUP, SCREW, STEM, SLEEVE); DOI: (B)(6) 2010 (HEAD, LINER); DOR: (B)(6) 2011; RIGHT HIP.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 9643392 ↗
• InjuryDec 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT TOTAL HIP REVISION DUE TO INSTABILITY. DOI: (B)(6) 2019. DOR: (B)(6) 2019. RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 9425638 ↗
• InjuryApr 29, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS PAIN DUE TO RECURRENT DISLOCATIONS/INSTABILITY (LEFT HIP).

  Patient problems: Joint Dislocation; No Code Available; Pain

  MAUDE report 8561686 ↗
• InjuryMar 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. CONSTRAINED LINER. DOI: (B)(6) 2012. DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8427963 ↗
• InjuryApr 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR POSSIBLE INFECTION. I AND D WASH OUT WAS DONE. DOI: (B)(6) 2017; DOR; (B)(6) 2018; RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 7398763 ↗
• InjuryMar 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE 2 STAGE INFECTION OF ABC SPACER. DOI: CUP, ACT STEM- (B)(6) 2017, ; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 7327191 ↗
• InjurySep 5, 2017Disassembly; Fracture; Naturally Worn; Disassembly; Fracture; Naturally Worn

  DER STATES THAT PATIENT HAD A +5 28MM ARTICUL/EZE FEMORAL HEAD THAT WORE SUPERIOR THROUGH HER 28X48MM NEUTRAL ALTRX LINER, CAUSING APPROXIMATELY A QUARTER OF THE LIP OF THE LINER TO BREAK OFF. INITIAL SYNOPSIS WAS PERHAPS THE POLY WAS NOT FULLY IMPACTED AND SEATED IN THE CUP INITIALLY.

  Patient problems: No Information

  MAUDE report 6842530 ↗