PINNACLE ALTRX 1221-36-164Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295016465), received between Feb 26, 2018 and Dec 30, 2025 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HEAD LINER WASH OUT. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23923888 ↗
• InjuryJan 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION OF TOTAL HIP. SURGEON REMOVED THE HEAD AND LINER AND REPLACED WITH DIFFERENT CONSTRUCT. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21256425 ↗
• InjuryMay 16, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD IMPINGEMENT OF NECK FROM STEM, ON RIM OF LINER AND RESULTANT PAIN DISLOCATION, PRIMARY HIP (RIGHT) WAS DONE ON THIS PATIENT BY SAME SURGEON ON (B)(6) 2017. SURGEON BROUGHT PATIENT BACK TO OPERATING ROOM ON (B)(6) 2019 AND SWAPPED LINER FOR A CONSTRAINED LINER PLUS 4 NEUTRAL AND A 40MM +1.5 HEAD, STEM + CUP STAYED. DOI: (B)(6) 2017; DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: Joint Dislocation; Joint Disorder; No Code Available; Pain

  MAUDE report 8616142 ↗
• InjuryApr 9, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT RETURNED TO SURGERY FOR RECURRENT DISLOCATION. A CONSTRAINED LINER WAS PLACED. RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8497687 ↗
• InjuryDec 19, 2018Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT A WRONG SIZE HEAD WAS PUT IN.

  Patient problems: No Code Available

  MAUDE report 8180988 ↗
• InjurySep 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PENDING PRODUCT LIABILITY, CUSTOMER ALLEGES INFECTION AFTER FIRST REVISION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7920417 ↗
• InjuryMay 30, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS CHRONIC DISLOCATION. A 64MMX40MM CONSTRAINED LINER AND A BIOLOX 40X8.5 TS HEAD WERE UTILIZED. DOI: (B)(6) 2017; DOR: (B)(6) 2018 LEFT HIP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7553210 ↗
• MalfunctionFeb 26, 2018Difficult to Insert; Difficult to Insert

  PFS AND MEDICAL RECORDS RECEIVED. THERE IS NO ALLEGATIONS. AFTER REVIEW OF MEDICAL RECORDS FOR THE MDR REPORTABILITY, IT WAS REPORTED THAT THE LINER WAS NOT SEATING CORRECTLY AND WAS DAMAGED WHEN REMOVED FROM HIP. DOE: (B)(6) 2017. THIS PC IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7295624 ↗