PINNACLE 1219-32-260Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295014225), received between Jan 19, 2018 and Feb 16, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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.

• InjuryFeb 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WASHOUT OF A POTENTIAL INFECTED THR. PRIMARY PROCEDURE WAS DON ON (B)(6) 2009. PATIENT PRESENTED WITH SEVERE PAIN AND DISCOMFORT. BLOOD SHOWED INCREASE WITH WHITE CELLS AND SURGEON SUSPECTED AN INFECTION. NO GROSSLY CONTAMINATED INFECTED TISSUE COULD BE SEEN OR WAS SUPER OBVIOUS. MULTIPLE SPECIMENS TAKEN INTRA-OP FOR TESTING. FEMORAL HEAD AND POLY LINER REMOVED. MASSIVE WASHOUT COMPLETED AND NEW HEAD AND LINER WERE INSERTED INTO RIGHT HIP.

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

  MAUDE report 11332102 ↗
• InjuryFeb 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SOME PAIN SO THE SURGEON SWAPPED OUT THE POLY AND HEAD FOR A 40 LINER AND HEAD. UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 8325976 ↗
• InjuryJan 24, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS PATIENT HAS BEEN DISLOCATING SO IT WAS DECIDED TO CHANGE HIM TO A CONSTRAINED LINER. HE WENT FROM A 32MM HEAD TO A 36 CONSTRAINED. PATIENT CONSEQUENCE? :UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES. DOI: UNKNOWN; DOR: (B)(6) 2018, UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7214981 ↗
• InjuryJan 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2017; RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 7206379 ↗