NA 1363-58-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295032885), received between Dec 28, 2017 and Sep 20, 2018 — classified as 3 injuries.

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

• InjurySep 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. REMOVED COMPONENTS AND IMPLANTED PROSTALAC. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7893079 ↗
• InjurySep 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS EARLY SIGNS OF INFECTION. THE WOUND WAS IRRIGATED. NEW COMPONENTS WERE IMPLANTED FOLLOWED BY ANTIBIOTIC BEADS. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 7868176 ↗
• InjuryDec 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE STEM AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. HE WAS BROUGHT TO SURGERY FOR AN I&D WASH OUT AND UNI POLAR HEAD EXCHANGE. DURING SURGERY, IT WAS DISCOVERED THAT THE CEMENTED STEM WAS LOOSE AND HAD A BIOFILM, MUCUS TYPE FILM AROUND IT AND NEEDED TO BE REMOVED. A NEW SMALLER STEM AND UNI HEAD WERE THEN IMPLANTED. DOI: (B)(6) 2017. DOR: (B)(6) 2017. UNKNOWN AFFECTED SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 7150608 ↗

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