Profemur PHA00236Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M684PHA002361), received between Jan 6, 2020 and Nov 27, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 27, 2023Failure to Osseointegrate; Mechanical Jam; Failure to Osseointegrate; Mechanical Jam

  ALLEGEDLY, UNABLE TO REMOVE THE NECK, THE ENTIRE STEM WAS REMOVED. REPORTING PARTY'S FINDINGS AND RESPONSE STATUS: THERE MAY HAVE BEEN IMPURITIES IN THE NECK-STEM JOINT, OR THE STEM MAY HAVE STUCK DUE TO COLD FLOW. ADDITIONAL INFORMATION RECEIVED ON 2023-11-09: DURING NECK REMOVAL, THE STEM CAME OUT UNINTENTIONALLY (IS IT POSSIBLE THAT THE FIXATION OF THE STEM TO THE BONE WAS INSUFFICIENT). ADDITIONAL INFORMATION RECEIVED ON 2023-11-13: THE PRIMARY REASON FOR REVISION INVOLVED LOOSENING OF A NON-MPO CEMENTED CUP. DURING THIS SURGERY, THE PLAN WAS TO REVISE THE NECK AND HEAD UNLESS INFECTION/LOOSENING OF THE STEM WAS ALSO FOUND. NO INFECTION WAS FOUND, AND ONLY THE NECK WAS TO BE REMOVED. HOWEVER, THE SURGICAL TEAM COULD NOT REMOVE THE NECK FROM THE STEM WHICH RESULTED IN FULL REVISION OF THE FEMORAL STEM AS WELL. JAPAN (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18210481 ↗
• InjuryMay 30, 2022Loss of Osseointegration; Device Dislodged or Dislocated; Loss of Osseointegration

  ALLEGEDLY, THE CT REPORT ON 08/2021 SHOWS A DISLOCATION OF THE ACETABULAR PART OF THE HIP ENDOPROSTHESIS, OSTEOLYSIS AND PAIN. THE SAME RESULT ALSO SHOWS THAT OLDER RADIOGRAPHS SHOW A SIGNIFICANT REACTION IN THE AREA OF THE LEFT HIP WITH LAYERS ALONG THE LEFT HIP PROSTHESIS. PX PERFORMED AN X-RAY ON (B)(6) 2021 AND THE RESULTS SHOW THAT THERE WAS THINNING OF THE BONE IN THE ACETABULAR PART OF THE ENDOPROSTHESIS AND IN THE FEMUR. LOSS OF MOBILITY DUE TO PAIN. PRODUCTS NOT REVISED, ALLEGEDLY REVISION SURGERY SCHEDULED FOR JUNE 2022.

  Patient problems: Metal Related Pathology; Osteolysis; Pain

  MAUDE report 14545117 ↗
• InjuryJun 30, 2020Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO STEM ASEPTIC LOOSENING. ITEMS NOT REVISED: COTYLE "ANCA" AVEC TROUS A/REVET. HAP 56, CATALOG # PPR67256, LOT # U0362491, QTY 1. INSERT CERAM "ANCA FIT?" 28/44 56-58/28 AL2.O3 BIOLOX FORTE, CATALOG # PPR67512, LOT # T12139243, QTY 1.

  Patient problems: No Information

  MAUDE report 10213080 ↗
• InjuryMay 20, 2020Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO STEM ASEPTIC LOOSENING+BONE FRACTURE COMPONENTS NOT REVISED: COTYLE "ANCA" AVEC TROUS A/REVET. HAP 52, PPR67252, LOT: S091112475, INSERT CERAM "ANCA FIT?" 28/40 50-52-54/28 AL2.O3 BIO. FORTE PPR67510, LOT: T03121242.

  Patient problems: Bone Fracture(s)

  MAUDE report 10074700 ↗
• InjuryJan 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY PATIENT WAS REVISED DUE TO UNKNOWN REASONS. LEFT HIP.

  Patient problems: No Information

  MAUDE report 9555143 ↗