PROFEMUR® PRGLCM04Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M684PRGLCM041), received between May 19, 2020 and Aug 29, 2021 — 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.

• InjuryAug 29, 2021Loss of Osseointegration; Loss of Osseointegration

  SADE # (B)(4). ALLEGEDLY, PATIENT WAS REVISED DUE TO PAIN AND LOOSENING. TROCHANTERIC NON-UNION DUE TO INADEQUATE REATTACHMENT AND OR EARLY WEIGHT BEARING. HE HAS HAD LACK OF INGROWTH OF THE ACETABULAR COMPONENT. OPERATIVE SIDE: RIGHT. THE DYNASTY BIOFAM SHELL, DYNASTY A-CLASS POLYLINER, AND SCREWS WERE REVISED. COMPONENTS NOT REVISED: PRODUCT NAME: PROFEMUR® NECK A/R 8DG SHORT COBALT CHROME CATALOG NUMBER: PHAC1232 LOT NUMBER: 1407107. PRODUCT NAME: PROFEMUR® GLADIATOR® CEMENTED STEM SZ 4 CATALOG NUMBER: RGLCM04 LOT NUMBER: 1453286. PRODUCT NAME: CONSERVE® A-CLASS® BFH® HEAD SHORT NECK 36MM CATALOG NUMBER: 38AM3604 LOT NUMBER: 1452346.

  Patient problems: Pain

  MAUDE report 12381673 ↗
• InjuryJun 25, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SAE # (B)(4): ALLEGEDLY, THE PATIENT HAD A LUXATION OF THE RIGHT HIP WITH PERIPROSTHETIC FRACTURE. JOINT REDUCTION PERFORMED ON (B)(6) 2017. SAE # (B)(4): ALLEGEDLY, PATIENT SAT ON THE SOFA. WHEN LIFTING THE RIGHT LEG, THE HIP LUXATED. RECOVERED AFTER REMOVING HEAD AND MODULAR NECK OF THE RIGHT HIP. (B)(6) CASE NUMBER: (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 12071326 ↗
• InjurySep 7, 2020Use of Device Problem; Device Dislodged or Dislocated; Use of Device Problem; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS SQUATTING WHICH LEAD OUT A LUXATION OF THE IMPLANTED HIP; LATER IT COULD BE REPOSITIONED BY CLOSED REPOSITION.

  Patient problems: No Information

  MAUDE report 10499540 ↗
• InjuryMay 19, 2020Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, REVISED DUE TO TOTAL ASEPTIC LOOSENING.

  Patient problems: No Information

  MAUDE report 10072314 ↗