P.F.C. 85-7723Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295215196), received between Dec 27, 2017 and Nov 16, 2021 — classified as 5 injuries.

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

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

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 12819621 ↗
• InjuryFeb 23, 2021Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  THE PATIENT WAS REVISED DUE TO RECURRENT DISLOCATIONS WITH INDICATION OF POLY LINER WEAR. NO SURGICAL DELAY. DOI: (B)(6) 1998, DOR: (B)(6) 2021, LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 11367212 ↗
• InjuryFeb 24, 2020Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR OLD PATIENT COMPLAINS OF PAIN IN HIP SO THE SURGEON BROUGHT PATIENT IN FOR POLY SWAP. NO COMPONENTS WERE LOSE OR DAMAGED. HEAD WAS REMOVED. AFTER MANY MINUTES THE POLY LINER WAS REMOVED, THE AID OF OSTEOTOMES AND OTHER INSTRUMENTS WAS NEEDED TO REMOVE THE EXISTING POLY. ONCE REMOVED THE POLY WAS DAMAGED AND SIZES WERE NOT RECOGNIZABLE. TRIALS WERE NOT AVAILABLE DUE TO EMERGENT STATUS OF THE PROCEDURE. AN APPROXIMATE SIZED IMPLANT WAS OPENED AND WAS INCORRECT. WE THEN OPENED THE CORRECT SIZE AND IMPLANTED SUCCESSFULLY. A REPLACEMENT HEAD WAS OPENED AND PROCEDURE WAS COMPLETE. DOI: UNKNOWN. DOR: (B)(6) 2020, UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 9745903 ↗
• InjuryAug 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. ALL IMPLANTS WERE REMOVED AND REPLACED WITH PROSTALAC. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 7777265 ↗
• InjuryDec 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE SURGEON SAID THE LINER HAD ECCENTRIC WEAR. THE SURGEON EXPLANTED THE LINER AND FEMORAL HEAD AND IMPLANTED A NEW LINER AND FEMORAL HEAD. THE HOSPITAL HAS THE EXPLANTS. THE LOT NUMBERS WERE ILLEGIBLE. DOI: UNKNOWN; (B)(6) 2017; RIGHT HIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7149094 ↗