NA 1363-14-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295032694), received between Nov 27, 2017 and Jul 31, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE SURGEON BROKE THE SPACER TRIAL TRYING TO EXTRACT IT FROM MODULAR HEADBALL. AFFECTED SIDE: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675430 ↗
• 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 22292859 ↗
• InjuryFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A HEMI AND WAS PAINFUL POST OP SO WE CONVERTED TO THA WITH DUAL MOBILITY. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Pain

  MAUDE report 18699169 ↗
• InjuryJan 25, 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 13342550 ↗
• 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 8798574 ↗
• InjuryMay 28, 2019Migration; Migration

  IT WAS REPORTED THAT THE PATIENT¿S HEMIARTHROPLASTY WAS MIGRATING SUPERIOR IN THE SOCKET AND NEEDED REVISION. DOI: (B)(6) 2019. DOR: MAY 7, 2019. RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 8645666 ↗
• InjuryNov 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 7061160 ↗

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