Profemur PHA01244Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI M684PHA012441), received between Mar 9, 2020 and Feb 27, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Break” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, LOOSENING - SOCKET/LYSIS - STEM/LYSIS - SOCKET/WEAR OF ACETABULAR COMPONENT SIDE: R. REVISION NJR: 4080719. GENDER: F. EXPLANTED: FEMORAL STEM, ACETABULAR CUP, MODULAR HEAD, ACETABULAR CEMENT.

  Patient problems: Osteolysis

  MAUDE report 18787512 ↗
• InjuryMar 16, 2021Break; Break

  ALLEGEDLY, SUDDEN SAGGING AND CRACKING OF THE HIP, HE COULD NO LONGER STRAIN. NECK BROKE. ADDITIONAL INFORMATION RECEIVED ON 02/17/2021: EXACT IMPLANTING DATE RECEIVED (B)(6) 2009, AND CONFIRMATION THAT THE STEM WAS NOT REVISED. ADDITIONAL INFORMATION RECEIVED ON 02/18/2021: LOT NUMBER FOR THE FEMORAL HEAD. ADDITIONAL INFORMATION RECEIVED ON 02/25/2021: INCIDENT DESCRIPTION, CONFIRMATION OF COMPONENTS REVISED, IMPLANTATION AND REVISION DATE. ALLEGEDLY, THE NECK FRACTURED. ADDITIONAL INFORMATION RECEIVED ON 02/26/2021: CONFIRMATION OF PRODUCT ID AND LOT NUMBER FOR FEMORAL HEAD, INDICATION THAT THERE WERE NO DEFICIENCIES AGAINST THIS COMPONENT. COMPONENT NOT REVISED: PROFEMUR E+ STEM GR 5 PRODUCT ID: PHA03165. BFARM CASE NUMBER: (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11495213 ↗
• InjuryMar 8, 2021Break; Break

  ALLEGEDLY, SUDDEN SAGGING AND CRACKING OF THE HIP, HE COULD NO LONGER STRAIN. NECK BROKE. ADDITIONAL INFORMATION RECEIVED ON 02/17/2021: EXACT IMPLANTING DATE RECEIVED (B)(6) 2009, AND CONFIRMATION THAT THE STEM WAS NOT REVISED. ADDITIONAL INFORMATION RECEIVED ON 02/18/2021: LOT NUMBER FOR THE FEMORAL HEAD. COMPONENT NOT REVISED: PROFEMUR E+ STEM GR 5 PRODUCT ID: PHA03165. (B)(6).

  Patient problems: Insufficient Information

  MAUDE report 11436722 ↗
• InjuryNov 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: (B)(4). SIDE:L. PRIMARY ASA: P1 - FIT AND HEALTHY. MHRA REFERENCE NO: (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 10913683 ↗
• InjuryNov 18, 2020Break; Break

  ALLEGEDLY, PATIENT FELT SOMETHING CLUNK OR MOVE, TOOK ONE MORE STEP, FELT A SEVERE JOLT IN HIS GROIN AND FELL. X RAYS SHOWED A RIGHT FEMORAL NECK FRACTURE AT THE JUNCTION OF THE FEMORAL STEM COMPONENT WITH THE FEMORAL NECK. RECORDS STATE THE FRACTURE CAUSED DISLOCATION AND DISPLACEMENT OF HIS HIP JOINT. THE FRACTURE WAS IN THE FEMORAL NECK/STEM MODULAR JUNCTION.

  Patient problems: No Information

  MAUDE report 10864720 ↗
• InjuryAug 27, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PROSTHESIS DISLOCATION .COMPONENTS NOT REVISED: PPR67622 TIGE "ANCA FIT?" REV. HAP 1/3 PROXIMAL 15G S09112159.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10462703 ↗
• InjuryApr 6, 2020Material Disintegration; Material Disintegration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION AND METALLOSIS IN THE NECK AND FEMORAL HEAD.

  Patient problems: Unspecified Infection

  MAUDE report 9930762 ↗
• InjuryMar 31, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO UNKNOWN REASONS.

  Patient problems: No Information

  MAUDE report 9903492 ↗
• InjuryMar 11, 2020Break; Break

  ALLEGEDLY, WHEN THE LEFT HIP IMPLANTS GOT EXPOSED THE NECK WAS FRACTURED. AN ATTEMPT WAS MADE TO REMOVE THE NECK REMNANT OUT OF THE STEM BUT IT WAS UNABLE. DR (B)(6) REMOVE THE STEM.

  Patient problems: Bone Fracture(s)

  MAUDE report 9821465 ↗
• InjuryMar 9, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO UNKNOWN.

  Patient problems: No Information

  MAUDE report 9808805 ↗