NA 1018-36-505Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295001386), received between Dec 1, 2018 and Sep 11, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT HIP WAS DISLOCATED DUE TO FALL. DOI: (B)(6) 2011. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 23033680 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S HEAD AND LINER WERE REVISED TO ADDRESS INSTABILITY. DOI: UNKNOWN, DOR: (B)(6) 2025 , AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 21970299 ↗
• InjuryAug 6, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION. NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 12289036 ↗
• InjuryJul 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INFECTION I & D. DOI: UNKNOWN, DOR: (B)(6) 2020, AFFECTED SIDE: UNKNOWN.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10320855 ↗
• InjuryFeb 11, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT HIP POSTERIOR DISLOCATION, INITIAL EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: UNKNOWN. DATE OF REVISION: (B)(6) 2018. DATE OF EVENT (ONSET): (B)(6) 2019. (RIGHT HIP). TREATMENT: CLOSED REDUCTION/MANIPULATION.

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

  MAUDE report 9693897 ↗
• InjuryAug 5, 2019Naturally Worn; Naturally Worn

  PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2005 - DOR: (B)(6) 2012, (RIGHT HIP).

  Patient problems: Foreign Body Reaction; No Code Available; Test Result

  MAUDE report 8861466 ↗
• InjuryMay 24, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES DISLOCATION WITH OPEN REDUCTION AFTER FIRST REVISION. AFTER REVIEW OF MEDICAL RECORDS, NO REVISION NOTES REPORTED. LINER WAS NO LONGER ADDED SINCE IT IS A NON-DEPUY PRODUCT. DOI: (B)(6) 2010 - DOR: NOT REPORTED (LEFT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 8640340 ↗
• InjuryApr 22, 2019Naturally Worn; Naturally Worn

  PPF ALLEGES ELEVATED METAL IONS, ABDUCTOR MUSCLE REPAIR, METAL WEAR AND METALLOSIS. LINER WILL NO LONGER BE ADDED SINCE IT IS A NON-METAL PRODUCT. (RIGHT HIP).

  Patient problems: Test Result; Tissue Damage

  MAUDE report 8536911 ↗
• InjuryDec 1, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES DISLOCATION.

  Patient problems: No Information

  MAUDE report 8122076 ↗