NA 1363-60-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295032892), received between Oct 7, 2020 and Nov 14, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT I&D FOR CONFIRMED INFECTION WITH HEAD EXCHANGE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23556051 ↗
• InjuryApr 13, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A ANTIBIOTIC HEMI SPACER PLACED ON (B)(6) 2021. THE PATIENT DISLOCATED THAT HEMI. DOCTOR REMOVED THE HEAD AND TAPER AND CEMENTED IN A LINER WITH BIPOLAR HEAD. DR TREATED PATIENT AS IF HE WAS STILL INFECTED. DOI: (B)(6) 2021. DOR: (B)(6) 2021; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 11657840 ↗
• InjuryOct 7, 2020Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  PINNACLE MOM LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES ACETABULAR BONE LOSS DEFICIENCY AND COMPLETE DISASSOCIATION, SOFT TISSUE METALLOSIS STAINING AND REQUIRED 2 ADDITIONAL HOURS TO COMPLETE THE REVISION RESULTING TO PAIN, INJURIES AND EMOTIONAL DISTRESS. PLAINTIFF IS SEEKING COMPENSATION FOR ALL THE SUFFERING. DOI: (B)(6) 2018; DOR: (B)(6) 2018: LEFT HIP 2ND REVISION.

  Patient problems: Foreign Body Reaction; Injury; No Clinical Signs, Symptoms or Conditions; No Code Available; Pain

  MAUDE report 10641939 ↗

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