Profemur PHA01234Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI M684PHA012341), received between Dec 5, 2019 and Nov 4, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. SRNJR NUMBER: (B)(6). SIDE: R. GENDER: F. NON MPO REVISED PRODUCTS: PRODUCT ID: PT106056, REGEN/RNGLC+ MULTI 56MM SZ 24. LOT: UNKNOWN. QTY: 1. PRODUCT ID: EP043654, E1 ABT STANDARD ACETAB LINER 36/54MM (SZ 24). LOT: UNKNOWN. QTY: 1.

  Patient problems: Unspecified Infection

  MAUDE report 20598923 ↗
• InjuryAug 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, THIS PATIENT WAS REVISED DUE TO INFECTION AND NOT A FAILURE OF THE NECK. ALL OF THE COMPONENTS WERE REVISED DUE TO INFECTION, NOT DUE TO COMPONENT FAILURE. IT HAD BEEN IMPLANTED FOR A NUMBER OF YEARS. THE NECK WAS LEFT ATTACHED TO THE REMOVAL DEVICE AND WAS LEFT IN THE INSTRUMENT TRAY AS AN OVERSIGHT FOLLOWING THE END OF THE SURGERY. ADDITIONAL INFORMATION RECEIVED ON 02/01/2024: SHELL AND LINER LOOKED TO BE ANOTHER SUPPLIER.

  Patient problems: Unspecified Infection

  MAUDE report 20044374 ↗
• InjuryOct 30, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION , SUBLUXATION AND MALALIGNMENT STEM. REVISION NJR NUMBER: 4502611. SIDE:R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. NO INFORMATION PROVIDED FOR STEM. ADDITIONAL INFORMATION RECEIVED ON 10/08/2020 FROM (B)(6): ADDING A NEW INCIDENT FOR THE STEM WITH PARTIAL PRODUCT INFORMATION. ADDITIONAL INFORMATION RECEIVED ON 11/09/2020 FROM (B)(6) : ADDING STEM PRODUCT NUMBER AND LOT BATCH. MHRA REFERENCE NO: (B)(4).

  Patient problems: No Information

  MAUDE report 10765619 ↗
• InjuryAug 4, 2020Corroded; Corroded

  ALLEGEDLY , THE SUSPICION OF ADVERSE REACTION TO METAL DEBRIS MAY BE ESPECIALLY BETWEEN NECK AND HEAD. DR. WANTS TO INVESTIGATE THE EXISTENCE OF ADVERSE REACTION TO METAL DEBRIS AS FOLLOWING. USED OUR PROFEMURXM, CHANGEABLE NECK, METAL HEAD ONLY AND USED DEPUY PINA CUP AND MARASON LINER 28MM DIAMETER FLAT. A FEW DAYS AGO, THE PATIENT COMPLAINED OF ABNORMAL NOISE FROM HIS JOINT SPINNING PREVENTION TAB OF 6 PIN CUP MARATHON LINER 4 OUT OF 6 DAMAGED. REPLACE WITH MARATHON LINER 32MM FLAT. OUR STEAM IS ALSO REPLACED WITH A CHANGEABLE NECK AR8 LONG AND A DELTA HEAD 32 MM LONG. (B)(6).

  Patient problems: No Information

  MAUDE report 10361476 ↗
• InjuryMar 31, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PROSTHESIS DISLOCATION.

  Patient problems: No Information

  MAUDE report 9907455 ↗
• InjuryMar 6, 2020Loosening of Implant Not Related to Bone-Ingrowth

  ALLEGEDLY, PATIENT WAS REVISED DUE TO SEPTIC LOOSENING.

  Patient problems: Unspecified Infection

  MAUDE report 9797946 ↗
• InjuryFeb 18, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PAIN WITHOUT LOOSENING. ITEMS NOT REVISED: COTYLE "ANCA FIT?" SANS TROUS A/REVET. HAP 50, CATALOG # PPR67350, LOT # S03101591, QTY 1. INSERT CERAM "ANCA FIT?" 28/40 50-52-54/28 AL2.O3 BIO. FORTE, CATALOG # PPR67510, LOT # S02102352, QTY 1.

  Patient problems: Pain

  MAUDE report 9722966 ↗
• InjuryDec 5, 2019Break; Break

  ALLEGEDLY, PATIENT REVISED DUE TO FEMORAL NECK FRACTURE.

  Patient problems: No Information

  MAUDE report 9415914 ↗