DJO SURGICAL 804-03-051Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888912148184), received between Sep 27, 2019 and Apr 16, 2026 — classified as 7 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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.

• MalfunctionApr 16, 2026Mechanical Problem

  INTRUMENT FAILURE - BASEPLATE INSERTER CROSS THREADED DURING IMPACTION - INSERTER WAS STUCK TO GLENOSPHERE. ALL COMPONENTS INCLUDING BASEPLATE WERE RIPPED OUT AS ONE PIECE. SURGERY WAS COMPLETED AS INTENDED WITH NEW BASEPLATE, 2 HOUR DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24906084 ↗
• MalfunctionMar 3, 2026Mechanical Problem

  COMPLAINT - THE GLENOSPHERE INSERTER COLD WELDED TO THE GLENOSPHERE TRIAL CAUSING A 30 MINUTE DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24503749 ↗
• InjuryJan 16, 2026Detachment of Device or Device Component

  INSTRUMENT FAILURE - GLENOSPHERE INSERTER BROKE DURING IMPLANTATION OF GLENOSPHERE COMPONENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24090831 ↗
• InjuryApr 25, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  INSTRUMENT FAILURE - THE TIP OF THE INSERTER BROKE OFF IN THE GLENOSPHERE WHILE IMPACTING, BROKEN FRAGMENTED PIECES LEFT IN THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21915077 ↗
• InjuryApr 30, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THERE WAS A 45 MINUTE DELAY IN SURGERY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19218419 ↗
• InjuryApr 1, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THERE WAS A 20-30 MINUTE DELAY IN SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 19016779 ↗
• InjuryDec 13, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PIECE LEFT IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18323651 ↗
• InjuryAug 25, 2023No Apparent Adverse Event; No Apparent Adverse Event

  INSTRUMENT FAILURE - PIECES LEFT IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17628409 ↗
• MalfunctionJun 2, 2023No Apparent Adverse Event; No Apparent Adverse Event

  INSTRUMENT FAILURE - INSTRUMENT BROKE, PARTS LEFT IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17046484 ↗
• InjuryMar 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - 20 MINUTE DELAY IN SURGERY.

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

  MAUDE report 16603655 ↗
• MalfunctionMay 11, 2022Therapeutic or Diagnostic Output Failure

  INSTRUMENT FAILURE - DURING IMPLANTATION OF A SIZE 40 SPHERE, THE TIP OF THE T-HANDLE BROKE OFF INSIDE OF THE IMPLANT WHICH CAUSED THE SURGEON TO HAVE WASTE AN IMPLANT. HE THINKS THAT THE HANDLE BROKE BEFORE IMPACTION.

  Patient problems: Insufficient Information

  MAUDE report 14364748 ↗
• MalfunctionDec 31, 2020Break; Physical Resistance/Sticking

  INSTRUMENT FAILURE - THE GLENOSPHERE TRIAL THREADS WERE STRIPPED AND GOT STUCK IN THE PATIENT. THE IMPACTOR TIP SNAPPED OFF INSIDE THE GLENOID TRIAL. NO PIECES OF THE BROKEN INSTRUMENTS REMAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11101817 ↗
• MalfunctionDec 12, 2019Break

  INSTRUMENT FAILURE - THE THREADED PORTION BROKE OFF WHILE THE SURGEON WAS INSERTING IT. THE BROKEN PIECE BROKE OFF IN THE GLENOID HEAD IMPLANT AND WAS NOT PROTRUDING WITH NO WAY TO GET OUT, SO SURGEON LEFT PIECE IN PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9458865 ↗
• MalfunctionSep 27, 2019Break

  INSTRUMENT FAILURE - THE TIP OF THE INSERTER BROKE OFF INSIDE OF THE IMPLANT. THE IMPLANT IS STILL IN THE PATIENT. SURGERY WAS COMPLETED BUT NOT WITH THE IDEAL OUT COME WITH THE BROKEN PIECE LEFT IN PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9130288 ↗