PROFEMUR® PPW38354Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M684PPW383541), received between Aug 30, 2021 and Jun 3, 2024 — classified as 6 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. How this data works · Data updated Oct 13, 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.

• InjuryJun 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, ALL (B)(6) MEDICAL COMPONENTS REVISED DUE TO UNKNOWN REASONS. NON-MPO EXPLANTED PRODUCTS: PRODUCT ID: 623-00-44F STYKER TRIDENT X3 POLYETHYLENE INSERT/ LOT. NUMBER: 07613327025422/ QTY: (B)(4) .

  Patient problems: Insufficient Information

  MAUDE report 19446499 ↗
• InjuryMay 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, THE PROFEMUR® TOTAL HIP SYSTEM IMPLANTED IN PLAINTIFF FAILED, AND NECESSITATED TOTAL REVISION SURGERY. ABOUT (B)(6) 2022, RIGHT HIP WAS DISCOVERED TO HAVE FAILED, DR RECOMMENDED THE REVISION SURGERY AFTER PLAINTIFF PRESENTED WITH SEVERE PAIN AND LACK OF MOBILITY AND TO REMOVE THE SOURCE OF METALLOSIS.

  Patient problems: Loss of Range of Motion; Metal Related Pathology; Pain

  MAUDE report 16993489 ↗
• InjuryJan 2, 2023Corroded; Material Frayed; Corroded; Material Frayed

  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 ON (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 ON (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 ON (B)(6) 2020, REVISION SURGERY DOCTOR FOUND THE ACETABULAR COMPONENT (THE CUP) TO BE WELL FIXED WITH A CERAMI

  Patient problems: Metal Related Pathology; Nerve Damage; Pain

  MAUDE report 16083128 ↗
• InjurySep 3, 2021Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, A PATIENT WAS REVISED FOR STEM LOOSENING. COMPONENTS NOT REVISED: UNKNOWN SHELL, UNKNOWN PART ID.

  Patient problems: Insufficient Information

  MAUDE report 12422375 ↗
• InjuryAug 31, 2021Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, A PATIENT WAS REVISED FOR STEM LOOSENING.

  Patient problems: Insufficient Information

  MAUDE report 12402340 ↗
• InjuryAug 30, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, A PATIENT WAS REVISED FOR DISLOCATION.

  Patient problems: Insufficient Information

  MAUDE report 12388503 ↗