PINNACLE ALTRX 1221-28-052Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295015963), received between Dec 11, 2019 and Mar 22, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT FEMALE HAD HER HIP REPLACED ON (B)(6) 2015. RECENTLY SHE DISLOCATED HER HIP. SO THE DR. DECIDED TO DO A HEAD AND LINER AND EXCHANGE USING A LARGER HEAD TO IMPROVE HER STABILITY. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. IT WAS MENTIONED THAT THE LOT NUMBER OF HEAD COULD NOT BE READ. DOI- (B)(6) 2015. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 16591487 ↗
• InjuryJun 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION COMPLETED DUE TO PATIENT SUFFERING A DISLOCATION. AFTER THE SURGEON OPENED HER UP, HE NOTICED THAT THE POLY LINER DISASSOCIATED FROM THE SHELL. THERE WAS LOOSENING OF THE POLY LINER. DOI: (B)(6) 2013. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 14603483 ↗
• InjuryJun 23, 2020Device Dislodged or Dislocated; Naturally Worn; Noise, Audible; Device Dislodged or Dislocated; Naturally Worn; Noise, Audible

  IT WAS REPORTED THAT PATIENT PRESENTED WITH A PAINFUL HIP AFTER HEARING A POPPING SOUND. SURGEON BELIEVED THE POLY LINER MAY HAVE DISASSOCIATED AND ELECTED TO REVISE THE HIP. THE POLY LINER WAS DISASSOCIATED AND MANY OF THE LOCKING TABS WERE WORN AWAY. SURGEON DILIGENTLY INSPECTED THE LOCKING MECHANISM FOR DAMAGED AND ELECTED TO PLACE A NEW POLY IN THE EXISTING CUP AND EXCHANGE THE 28 BCERAMIC HEAD FOR A TS CERAMIC 36 HEAD. DOI: (B)(6) 2012, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10184462 ↗
• InjuryDec 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. ALL INFORMATION AVAILABLE HAS BEEN INCLUDED THAT COULD BE ATTAINED. NO INSTRUMENTS WERE BROKEN DURING SURGERY. DOI: UNKNOWN, DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: Joint Disorder; No Code Available

  MAUDE report 9450676 ↗