PINNACLE ALTRX 1221-28-148Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295016007), received between Mar 14, 2019 and Sep 15, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2023Fracture; Fracture

  PATIENT WAS REVISED DUE TO FRACTURED LINER. THERE WAS NO SURGICAL DELAY. DOI: JULY 22, 2020. DOR: (B)(6), 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 17760682 ↗
• InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN INFECTED HIP. DOI: UNKNOWN, DOR: (B)(6) 2020, AFFECTED SIDE: UNKNOWN.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10684940 ↗
• InjuryMay 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL HIP. DOI: UNKNOWN. DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10057149 ↗
• InjuryDec 13, 2019Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED FOR VERTICAL CUP AND BROKEN LINER. THE SURGEON REVISED CUP, LINER, AND HEAD. METALLOSIS WAS OBSERVED BECAUSE THE HEAD HAD WORN THROUGH THE LINER AND WAS ARTICULATING ON THE SHELL. METAL IONS ARE NOT KNOWN. NO FURTHER PATIENT INFORMATION AVAILABLE. DOI: 2003. DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: Foreign Body Reaction; No Code Available

  MAUDE report 9467078 ↗
• InjuryMay 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A TOTAL HIP ARTHROPLASTY WAS PERFORMED DUE TO CHRONIC HIP DISLOCATION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8619305 ↗
• InjuryMar 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PT HAD PRIMARY L-THR ON (B)(6) 2010. PT HAD SUBSEQUENT LINER DISASSOCIATION AND WAS REVISED. A DER WAS WRITTEN AND SUBMITTED AT THAT TIME. NOW, PT HAD ANOTHER LINER DISASSOCIATION. SURGEON ELECTED TO CEMENT A STRKYER 28MM LINER INTO PINNACLE CUP, FEARING YET A THIRD LINER WOULD DISASSOCIATE.

  Patient problems: No Code Available; Pain

  MAUDE report 8419753 ↗