P.F.C. 85-3831Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295207597), received between Sep 13, 2018 and Sep 29, 2022 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD HIP INSTABILITY DUE TO POLY WEAR AND POOR CUP PLACEMENT IN EXTREME INCLINATION. NEW CUP IMPLANTED. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 15501235 ↗
• 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 12819618 ↗
• InjuryMay 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS HIP DISLOCATION. NEW HEAD AND LINER. DOI: UNKNOWN. DOR: (B)(6) 2021. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 11765315 ↗
• InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON PLANNED FOR A RIGHT HIP REVISION OF A (B)(6) FEMALE. PATIENT HAD A P.F.C. CEMENTED HIP, A PFC CUP, PFC LINER, 28+0 HEAD AND 2 SCREWS. ALL REMOVED AND REPLACED WITH A REVISION. HAD WE BEEN ABLE TO SOURCE A REPLACEMENT PFC ACETABULAR LINER AND ALL 28 AND 32 PFC HEAD OPTIONS, THIS SURGERY WOULD HAVE TAKEN 30 MINUTES INSTEAD OF 4 HOURS. THE SURGEON WAS AWARE OF THE LIMITED AVAILABILITY AND HIS PLAN A IF EVERYTHING WENT WELL WAS JUST TO CHANGE THE PFC HEAD WITH A 32+0 OPTION (ONLY ONE AVAILABLE) AND A MULTI HOLE GRIPTION CUP WITH A 32 ALTRX LINER. HOWEVER, PATIENT WAS MORE UNSTABLE THAN EXPECTED SO THE SURGEON REMOVED THE STEM&CEMENT, REMOVED CUP, LINER, SCREWS AND HEAD. REPLACED WITH A STRYKER DM CUP AND A LONG CEMENTED EXETER.

  Patient problems: No Code Available

  MAUDE report 10756542 ↗
• InjuryMay 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS AN ALLEGATION OF PAIN.

  Patient problems: No Code Available; Osteolysis; Pain

  MAUDE report 8624081 ↗
• InjurySep 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 1993; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Not Applicable; Pain

  MAUDE report 7872315 ↗