NA 1363-45-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10603295032779), received between Oct 11, 2017 and Aug 17, 2026 — classified as 30 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 31 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 50288724 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FAILED HEMI HIP DUE TO ACETABULAR FRACTURE. PATIENT WAS REVISED TO TOTAL HIP WITH COMPETITOR'S CUP. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE-RIGHT HIP.

  Patient problems: Bone Fracture(s)

  MAUDE report 24306099 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23544823 ↗
• InjuryOct 30, 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. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23430464 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM INFECTION. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23378392 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: THE CATHCART FEMORAL HEAD WAS REVISED FOR INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 22665732 ↗
• 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 22214711 ↗
• InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HIP HEMIARTHROPLASTY WAS REVISED DUE TO PAIN. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 22148292 ↗
• InjuryMar 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO HEMIARTHROPLASTY DISLOCATION. PATIENT WAS REVISED TO A THA. THERE WAS NOT A SURGICAL DELAY OR ANY PATIENT CONSEQUENCES. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21641624 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HEMIARTHROPLASTY DONE ON (B)(6) 2021. TODAY, THE SURGEON REMOVED THE MODULAR CATHCART HEAD HIP BALL AND THE TAPERED SPACER AND PUT IN A 48MM ACETABULAR CUP, LINER, AND REVISION HEAD BALL. THE REASON FOR THE HIP REVISION SURGERY WAS THE PATIENT WAS EXPERIENCING PAIN. THERE WAS NO ISSUES WITH THE PREVIOUS IMPLANTS FAILING. THERE WAS NO DELAY IN THE SURGERY. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 20426876 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. COMPONENTS WERE REMOVED AND REPLACED WITH A PROSTALAC STEM. NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: NOVEMBER 26, 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18257500 ↗
• InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HEAD EXCHANGE DUE TO INFECTION. NO FURTHER INFORMATION AVAILABLE. DOI- UNKNOWN, DOR- (B)(6) 2023, AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16271349 ↗
• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15439895 ↗
• InjuryJan 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CONTINUES TO DRAIN AFTER HEMI ARTHROPLASTY. SURGEON PERFORMS I&D WITH EVACUATION OF HEMATOMA. HEAD IS EXCHANGED AS A PRECAUTION. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SITE: RIGHT HIP.

  Patient problems: Fluid Discharge; Hematoma

  MAUDE report 13268105 ↗
• MalfunctionDec 17, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE DEPUY STICKER WAS ATTACHED DIRECTLY TO THE FEMORAL HEAD IMPLANT INSTEAD OF THE BLUE PLASTIC IT IS SUPPOSED TO BE ATTACHED TO. IMPLANT WAS IMMEDIATELY REMOVED FROM STERILE FIELD AND A NEW IMPLANT WAS OPENED. SURGERY TIME WAS EXTENDED BY 2 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13025953 ↗
• InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCING DISCOMFORT. REVISED HIP FROM HEMI TO THA. DOI: (B)(6) 2020. DOR: (B)(6) 2021. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Discomfort

  MAUDE report 12562202 ↗
• InjuryAug 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PAINFUL HEMIARTHROPLASTY. CONVERTED TO TOTAL HIP. DOI: (B)(6) 2017; DOR: (B)(6) 2021; AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 12383756 ↗
• InjuryAug 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESECTION ARTHROPLASTY / GIRDLESTONE DUE TO INFECTION. NOTHING REIMPLANTED. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2014; DOR: (B)(6) 2021; LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12301525 ↗
• InjuryJul 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTION. DOI: (B)(6) 2021. DOR: (B)(6) 2021; LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12217485 ↗
• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT I&D DUE TO INFECTION. DOI: (B)(6) 2021. DOR: (B)(6) 2021; (UNKNOWN SIDE).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11589356 ↗
• InjuryMar 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN I&D WAS DONE DUE TO A HEMATOMA. NO IMPLANTS WERE REMOVED. DOI: (B)(6) 2021; DOE: (B)(6) 2021; UNKNOWN AFFECTED SIDE.

  Patient problems: Hematoma

  MAUDE report 11574726 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. I&D CONVERTED HEMI TO CEMENTED LINER TOTAL HIP. NO ADDITIONAL INFORMATION. NO SURGICAL DELAY. DOI: (B)(6) 2019; DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10666620 ↗
• InjuryApr 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD HEMI HIP ON (B)(6) 2020. HIP DISLOCATED AND STEM WAS LOOSE IN CEMENT MANTLE. DOI: (B)(6) 2020. DOR: (B)(6) 2020; AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9944457 ↗
• InjuryApr 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED FOR 4TH TIME AND POSSIBLY STILL INFECTED. CHANGING OUT UNIPOLAR HEAD TO FIXED GRIPTION CUP WITH CONSTRAINED LINER. DOI: (B)(6) 2020. DOR: (B)(6) 2020; AFFECTED SITE: LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available; Unspecified Infection

  MAUDE report 9922574 ↗
• InjuryJan 13, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO CHRONIC DISLOCATION. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9582082 ↗

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