NA 1363-50-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295032823), received between Nov 27, 2017 and Jun 24, 2026 — classified as 14 injuries.

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD HEAD AND SLEEVE EXCHANGE ON I&D OF HEMIARTHROPLASTY W/ INFECTION. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 25606568 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED THE PAINFUL HEMIARTHROPLASTY. IT WAS CONVERTED TO TOTAL HIP. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE- LEFT HIP.

  Patient problems: Pain

  MAUDE report 24073723 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOR: (B)(6), 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 16885486 ↗
• InjuryJun 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE DOCTOR REVISED THE PATIENTS FOR RECURRENT DISLOCATIONS. A NEW UNIPOLAR CONSTRUCT WITH A SUMMIT CEMENTED STEM WAS IMPLANTED (B)(6) 2022. NO FURTHER INFO IS KNOWN AT THIS TIME. NO SURGICAL DELAY. DOI: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP HEMI.

  Patient problems: Joint Dislocation

  MAUDE report 14852940 ↗
• InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS INFECTED, SURGEON DID A WASHOUT AND REPLACED ALL IMPLANTS.

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

  MAUDE report 11780199 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO INFECTION. RIGHT HIP HEMI-ARTHROPLASTY.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10620960 ↗
• InjuryApr 20, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD DISLOCATED HIS HEMI HIP. PATIENT WAS CONVERTED TO A TOTAL HIP. DOI: (B)(6) 2020; DOR: (B)(6) 2020; LEFT SIDE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9978792 ↗
• InjuryDec 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAINFUL HIP. CONVERTED MONOPOLAR HEMI HIP TO A TOTAL HIP. HE REMOVED THE HEAD AND SPACER. NUMBERS WERE NOT OBTAINABLE FROM THE SPACER. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2011; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 9476005 ↗
• InjuryJul 17, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT'S HIP IS TOO TIGHT. DOI: UNKNOWN, DOR: (B)(6) 2019, UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available

  MAUDE report 8798575 ↗
• InjuryJul 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON SAID THE PATIENT HAD ARTHRITIC PAIN IN THEIR ACETABULUM SO HE CONVERTED THEIR EXISTING HEMIARTHROPLASTY TO A TOTAL HIP USING A COMPETITOR CUP AND LINER. THE ORIGINAL IMPLANT DATE IS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 8754690 ↗
• InjuryJun 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE UNIPOLAR DISLOCATED. THE SURGEON DOWNSIZED HEAD AND CONVERTED TO BI POLAR. DOI: UNK; DOR: (B)(6) 2019; UNKNOWN HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8700412 ↗
• InjuryJun 18, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION AND INSTABILITY. DOI: (B)(6) 2018; DOR: (B)(6) 2018; UNKNOWN HIP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7609543 ↗
• InjuryNov 28, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 7065865 ↗
• InjuryNov 27, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 7061198 ↗

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