PINNACLE 1219-32-452Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295014331), received between Apr 2, 2019 and May 28, 2025 — classified as 5 injuries, 1 malfunction.

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 16, 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.

• MalfunctionMay 28, 2025Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS A DEFECT IN A POLYETHYLENE MARATHON LINER. THE INCIDENT HAPPENED DURING A THA SURGERY. WHEN THE TECHNICIAN OPENED THE ITEM, THE MATERIAL WAS VERY STICKY TO THE INNER PACK WHICH WAS OBVIOUSLY MELTED; TECHNICIAN TRIED TO GET THE LINER OUT, BUT THE MELTED PLASTIC PACK WAS BROKEN AND THE PRODUCT FELL TO THE FLOOR. ANOTHER SIZE LINER WAS AVAILABLE FOR USE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: Insufficient Information

  MAUDE report 22096119 ↗
• InjuryOct 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO UNSTABLE HIP AND CONVERTED TO A CONSTRAINED LINER. THERE WAS NO DELAY, NO HARM TO PATIENT. DOI: (B)(6) 2024, DOR: (B)(6) 2024 AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 20382080 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. DOI : (B)(6) 2021. DOR: (B)(6) 2021. HIP UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12861421 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. ALL IMPLANTS REMOVED. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2019, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

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

  MAUDE report 12200676 ↗
• InjuryNov 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO A DISLOCATION FROM A FALL. DOI: (B)(6) 2013; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9336948 ↗
• InjuryApr 2, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGED DISLOCATION AFTER FIRST REVISION.

  Patient problems: Joint Dislocation

  MAUDE report 8473479 ↗