NA 1363-12-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10603295032687), received between Nov 24, 2017 and Aug 17, 2026 — classified as 43 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent the revision surgery due to infected hip.DOI: Unknown.DOR: (b)(6) 2026.Affected Side: Left Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50288723 ↗
• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WASH OUT FOR INFECTION. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25506114 ↗
• InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HEMI REVISED TO TOTAL DUE TO PAIN. DOI: (B)(6) 2021, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT.

  Patient problems: Pain

  MAUDE report 25072991 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SIGNS OF INFECTION; I/D WAS PERFORMED AND HEAD/SLEEVE WERE REPLACED. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24333794 ↗
• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENTS UNIPOLAR BECAME PAINFUL AND WANTED A TOTAL HIP. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 24116971 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. ORIGINAL IMPLANT DATE WAS (B)(6) 2025.

  Patient problems: Unspecified Infection

  MAUDE report 22906924 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS INFECTED. SO, SURGEON WASHED THE PATIENT OUT AND PUT IN NEW COMPONENTS. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22332772 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PAINFUL SEMI HIP WAS CONVERTED TO TOTAL HIP. NO ADDITIONAL INFORMATION IS AVAILABLE. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 22318573 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ACETABULAR PAIN. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 22214817 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION IN THEIR HIP. SURGEON REMOVED EXISTING IMPLANTS AND PUT IN A PROSTALAC HIP SPACER. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22212014 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ARTHRITIC SOCKET. UNKNOWN SURGICAL DELAY. AFFECTED SIDE: UNKNOWN.

  Patient problems: Inflammation

  MAUDE report 22020395 ↗
• MalfunctionApr 1, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT REVISED FROM HEMI TO TOTAL. NO IMPLANT FAILURE. NO BROKEN PIECES. NO CASE DELAY. NO LOOSENING. THERE WAS NO PATIENT HARM. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT.

  Patient problems: Insufficient Information

  MAUDE report 21740542 ↗
• InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES.

  Patient problems: Unspecified Infection

  MAUDE report 19614067 ↗
• 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 18838271 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS AN INFECTION IN THE AREA. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2023. DOR- UNKNOWN. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17556033 ↗
• 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 17190100 ↗
• 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 17152854 ↗
• InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SUSPECTED INFECTION. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 16636689 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR HIP PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6), 2022. DOR: (B)(6), 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 16156578 ↗
• InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED FOR HIP PAIN. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 16114339 ↗
• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. NEW HEAD AND SPACER IMPLANTED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14594655 ↗
• 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 14471304 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POST SURGERY INFECTION. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14041511 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO MEDIAL ACETABULUM PAIN. DOI: (B)(6) 2017. DOR: (B)(6) 2021. (UNKNOWN SIDE).

  Patient problems: Pain

  MAUDE report 13250595 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD HER ORIGINAL ANTIBIOTIC SPACER PLACED ON (B)(6) 2021 THEN HAD IT WASHED OUT AGAIN ON (B)(6) 2021 AND IT WAS CONVERTED TO A HEMI AT THAT TIME. SHE HAD AN ASPIRATION ON THIS PAST THURSDAY BECAUSE HER HIP WAS PAINFUL AGAIN AND SHE IS NOW GROWING A DIFFERENT THEN SHE WAS BEFORE. THE DOCTOR HAS DECIDED TO REMOVE EVERYTHING IN THE HIP, WASH IT OUT AGAIN AND REDO THE ANTIBIOTIC SPACER. DOI: (B)(6) 2021; DOR: (B)(6) 2021 ; LEFT HIP.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 13010708 ↗

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