NA 1363-54-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295032861), received between Nov 2, 2017 and Nov 3, 2025 — classified as 20 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K903084); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS WERE REMOVED DUE TO INFECTION, WASHED OUT AND PUT NEW IMPLANTS IN. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23453477 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO HEMI HEAD SWAP FOR INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23450312 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISION AND COMPONENTS WERE REVISED DUE TO INFECTION. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22292791 ↗
• InjuryOct 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO. WAS THERE ANY ALLEGATION AGAINST THE AUGMENT? NO ALLEGATIONS.

  Patient problems: Joint Dislocation

  MAUDE report 20452750 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: NO DELAY.

  Patient problems: Joint Laxity

  MAUDE report 19143968 ↗
• InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED, PERFORMED I&D AND EXCHANGED CATHCART AND SPACER. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18845976 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION . IMPLANTS WERE EXTRACTED AND PROSTALAC WAS IMPLANTED. NO SURGICAL DELAY, NO OTHER INFORMATION IS AVAILABLE. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE : UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18838276 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: ON (B)(6) 2022, DOR: ON (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18302273 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IRRIGATION AND DEBRIDEMENT WAS DONE DUE TO INFECTION WITH MODULAR COMPONENT EXCHANGE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17190098 ↗
• InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED WITH IRRIGATION AND DEBRIDEMENT DUE TO INFECTION WITH HEAD EXCHANGE. NO SURGICAL DELAY. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17152851 ↗
• InjuryFeb 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATING HIP. PATIENT HAD A HEMI. THE SURGEON REVISED THE STEM AND PLACED ACETABULAR COMPONENT WITH CONSTRAINED LINER. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16277113 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROSTHESIS WAS REMOVED DUE TO INFECTION. NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14471338 ↗
• InjuryOct 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. I AND D WITH HEAD EXCHANGE. DOI: (B)(6) 2020. DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10763811 ↗
• InjuryJul 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD I&D OF THE HIP AND DOCTOR DECIDED TO CHANGE OUT THE HEAD BALL AND THE TAPERED SPACER. DOI: (B)(6) 2019; DOR: (B)(6) 2019; UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 8777469 ↗
• InjuryAug 21, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. PATIENT HAD HEMI HIP FOR FEMORAL NECK FRACTURE. HE DISLOCATED TWICE. HE DISLOCATED A 3RD TIME AND WAS REVISED TO A LONGER NECK AND NEW HEAD. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7800588 ↗
• InjuryAug 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES OF INFECTION AFTER FIRST REVISION. NO REVISION OPERATIVE NOTE HAS BEEN PROVIDED. THERE WAS NO LABORATORY RESULT FOR THE ALLEGED INFECTION. FIRST REVISION WAS CAPTURED UNDER (B)(4). DOI: (B)(6) 2010 -DOR: (B)(6) 2010 (RIGHT HIP) SECOND REVISION. (B)(4)-FIRST REVISION

  Patient problems: Unspecified Infection

  MAUDE report 7768092 ↗
• InjuryFeb 9, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  HIP DISLOCATED. PATIENT CONSEQUENCE? :UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 7258726 ↗
• InjuryJan 8, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2017; DOR: (B)(6) 2017. RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7172001 ↗
• InjuryNov 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT PATIENT HAD AN I&D AND REPLACED UNIPOLAR BALL AND SPACER ON (B)(6) 2017. TODAY, ALL COMPONENTS WERE REMOVED DUE TO INFECTION. A BIOMET ANTIBIOTIC HIP SPACER WAS PUT IN.

  Patient problems: Unspecified Infection

  MAUDE report 7048066 ↗
• InjuryNov 2, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS HIP PAIN FROM A PREVIOUS UNIPOLAR HEMIARTHROPLASTY. SURGEON ELECTED TO REVISE THIS PATIENTS HIP FROM A HEMIARTHROPLASTY TO A TOTAL HIP ARTHROPLASTY. IT WAS ALSO REPORTED THAT THE SURGEON UTILIZE A DEPUY FEMORAL HEAD SINCE HE ELECTED TO RETAIN THE WELL FIXED DEPUY FEMORAL STEM THAT WAS IMPLANTED DURING PREVIOUS OPERATION.

  Patient problems: Pain

  MAUDE report 6998352 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K903084. One submission often covers many models, so check the product and lot details in each record.

• Z-1375-2022 · May 18, 2022 · Open, Classified
  MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000, 136342000, 136343000, 136344000, 136345000, 13634600