PINNACLE 1219-36-164Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295014638), received between Feb 20, 2020 and Jan 17, 2022 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 17, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ORIGINAL IMPLANT DATE UNKNOWN. PATIENT EXPERIENCED INSTABILITY AND DISLOCATION SO THE DOCTOR DECIDED TO EXCHANGE THE POLY FOR A CONSTRAINED LINER. DOI: UNKNOWN. DOR-:(B)(6) 2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 13265868 ↗
• InjuryJul 21, 2020Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUOUSLY DISLOCATING. SURGEON CHOSE TO INTEROPERATIVELY CHECK STEM AND CUP FOR LOOSENING. ULTIMATELY KEPT BOTH STEM AND CUP AND CHOSE TO SWAP LINER WITH CONSTRAINING LINER AND REPLACEMENT HEAD. DOI: (B)(6) 2010, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10301282 ↗
• InjuryApr 1, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE SURGEON PERFORMED A POLY SWAP WITH HEAD REPLACEMENT. THE POLY HAD A SUBSTANTIAL AMOUNT OF WEAR ANTERIORLY. POLY AND HEAD WERE EXPLANTED AND A NEW POLY AND HEAD WERE IMPLANTED OF THE SAME SIZES. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME. DOI: UNKNOWN; DOR; (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 9910828 ↗
• InjuryFeb 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORD RECEIVED. THERE IS NO ALLEGATION AND NO REVISION REPORTED. DOI: (B)(6) 2005; DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9732624 ↗