DJO SURGICAL 540-54-075Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00190446254430), received between Feb 18, 2022 and Dec 17, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K013042); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT DEVELOPED AN INFECTION. THE CONDYLE KIT AND POLY WERE REMOVED, WASHED OUT PERFORMED AND A NEW COMPONENTS IMPLANTED. AGE/GENDER UNK.

  Patient problems: Unspecified Infection

  MAUDE report 23834915 ↗
• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO LOOSENING.

  Patient problems: Joint Laxity

  MAUDE report 22102169 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO PAIN AND INFECTION.

  Patient problems: Implant Pain; Unspecified Infection

  MAUDE report 19726856 ↗
• InjuryFeb 18, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY: DUE TO ELBOW FRACTURE AND IMPLANT LOOSE.

  Patient problems: Insufficient Information

  MAUDE report 13559280 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K013042. One submission often covers many models, so check the product and lot details in each record.

• Z-1925-2014 · May 15, 2014 · Terminated
  DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint replacement prostheses are intended for primary and revi
• Z-0032-2009 · May 23, 2008 · Terminated
  Biomet brand Discovery Elbow, 3 mm x 75 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; RE
• Z-0033-2009 · May 23, 2008 · Terminated
  Biomet brand Discovery Elbow, 3 mm x 115 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; R