PROFEMUR® PPW39102Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M684PPW391021), received between Aug 30, 2021 and Jul 19, 2022 — classified as 5 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. How this data works · Data updated Oct 13, 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.

• InjuryJul 19, 2022Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  ALLEGEDLY, ON (B)(6) 2019, WHILE IN HER HOME SITTING IN A REST POSITION, PATIENT FELT A SUDDEN PAIN IN THE HIP WITH ASSOCIATED FUNCTIONAL IMPOTENCE. THE FOLLOWING DAY SHE WAS TAKEN TO THE FAGGIANA ORTHOPEDIC INSTITUTE AND UNDERWENT A VISIT AND RADIOLOGICAL EXAMINATION: THE ? PROSTHETIC STEM BREAKAGE AT THE PROXIMAL THIRD ?. (RIGHT LEG) PATIENT WAS THEREFORE FORCED TO UNDERGO A NEW ARTHROPLASTY REVISION SURGERY ON THE RIGHT FEMORAL STEM WITH METAL OSTEOSYNTHESIS WITH CERCLAGE ON (B)(6) 2019. THE OPERATION WAS FOLLOWED BY A LONG HOSPITALIZATION THAT LASTED UNTIL (B)(6) 2019 DUE TO THE ONSET OF PERSISTENT FEVER. FOLLOWING HER DISCHARGE, PATIENT WAS FORCED TO UNDERGO FURTHER HOSPITALIZATIONS FOR THREE EPISODES OF DISLOCATION OF THE RIGHT HIP PROSTHESIS. PATIENT HAS COMPLETELY LOST THE ABILITY TO WALK, IF NOT FOR SHORT STRETCHES AND WITH THE HELP OF A WALKER AND A PERSON TO HELP HER.

  Patient problems: Fever; Pain

  MAUDE report 15052269 ↗
• InjuryMar 1, 2022Break

  ALLEGEDLY, PATIENT WAS EX DOMO (PROF R IMPLANTATION IN ANOTHER HOSPITAL). PROSTHESIS PSEUDO- ARTHRITIC, BROKEN STEM BELOW PROXIMAL PART. REGARDING A LOW GRADE INFECT AS DIFFERENTIAL DIAGNOSIS, STEM AND CUP EXPLANTED IN (B)(6) HOSPITAL. BFARM CASE NUMBER: (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 13639845 ↗
• InjurySep 1, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED ON 02,SEP, 2021. ALLEGEDLY, A PATIENT WAS REVISED FOR DISLOCATION.

  Patient problems: Failure of Implant

  MAUDE report 12407091 ↗
• InjuryAug 30, 2021Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, A PATIENT WAS REVISED FOR STEM LOOSENING.

  Patient problems: Insufficient Information

  MAUDE report 12388982 ↗
• InjuryAug 30, 2021Fracture; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION RECEIVED ON 02,SEP, 2021. ALLEGEDLY, A PATIENT WAS UNDERWENT A SUBSEQUENT PROCEDURE FOR GREATER TROCHANTER FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 12388671 ↗