Profemur PPW38024Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M684PPW380241), received between Oct 7, 2021 and Jan 5, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2023Break; Corroded; Difficult to Remove; Break; Corroded; Difficult to Remove

  ALLEGEDLY, ON (B)(6) 2010, PATIENT HAD A WRIGHT MEDICAL PROFEMUR R BOWED DISTAL STEM AND PROXIMAL BODY, MATED WITH A PROFEMUR PLUS COCR MODULAR NECK, IMPLANTED IN HIS LEFT HIP. ON (B)(6) 2020, PATIENT'S PROFEMUR R BOWED DISTAL STEM SUDDENLY AND WITHOUT WARNING FAILED, FRACTURING IN TWO NEAR THE TOP OF THE STEM, BELOW THE MORSE TAPER. ON (B)(6) 2020, PATIENT HAD A REVISION SURGERY PERFORMED ON HIS LEFT. IN THE COURSE OF THE (B)(6) 2020, REVISION SURGERY THE DOCTOR NOTED THAT THE PROXIMAL BODY AND HEAD WERE GROSSLY LOOSE AND WERE EXTRACTED BY HAND. SURGEON PERFORMED AN EXTENDED TROCHANTERIC OSTEOTOMY TO REMOVE THE DISTAL REMNANT OF THE FRACTURED PROFEMUR R BOWED DISTAL STEM. IN THE (B)(6) 2020, REVISION SURGERY THE WRIGHT MEDICAL PROFEMUR R BOWED DISTAL STEM, PROFEMUR PROXIMAL BODY, PROFEMUR PLUS COCR MODULAR NECK, AND CERAMIC FEMORAL HEAD WERE REMOVED FROM THE BODY OF THE PATIENT, AND REPLACED WITH STRYKER ARTIFICIAL DEVICES, INCLUDING A STRYKER RESTORATION MODULAR SIZE 15 195MM CURVED STEM, 25MM +0 PROXIMAL BODY AND A 32MM +4 DELTA CERAMIC HEAD. IN THE COURSE OF THE (B)(6) 2020, REVISION SURGERY DOCTOR FOUND THE ACETABULAR COMPONENT (THE CUP) TO BE WELL FIXED WITH A CERAMIC LINER A

  Patient problems: Metal Related Pathology; Osteolysis; Pain

  MAUDE report 16108265 ↗
• InjuryOct 7, 2021Break; Break

  ALLEGEDLY, THE PATIENT HAD PREVIOUSLY BEEN OPERATED ON TWICE, IN 2013 AND 2014. THIS TIME HE SUFFERED A STEM BREAK, HAVING TO UNDERGO SURGERY AGAIN FOR ITS REMOVAL. ADDITIONAL INFORMATION RECEIVED ON 03/01/2022 INCLUDING NEW PRODUCTS THAT WERE REVISED.

  Patient problems: Insufficient Information

  MAUDE report 12591208 ↗