DJO SURGICAL 510-99-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888912144773), received between Apr 5, 2016 and Apr 13, 2022 — classified as 11 injuries.

The most frequently reported specific device problem is “Fracture” (2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - SURGEON STATES THAT PATIENT HAS A LOT OF PAIN HAVING A HEMI SHOULDER IMPLANT.

  Patient problems: Pain

  MAUDE report 14105066 ↗
• InjuryJan 12, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - CONVERT TO REVERSE PATIENT HAD INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 13237933 ↗
• InjuryOct 12, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - CONVERTED HEMI SHOULDER TO A REVERSED SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 12618999 ↗
• InjurySep 7, 2021Break

  REVISION SURGERY - SCREW REMOVAL FROM PREVIOUS REVERSE SHOULDER. BROKEN SCREWS WERE REMOVED FROM GLENOID. THEY PUT ON A NEW ADAPTER AND HEMI TURON HEAD.

  Patient problems: Insufficient Information

  MAUDE report 12432816 ↗
• InjuryJun 14, 2021Appropriate Device Problem Term/Code Not Available

  SECOND REVISION SURGERY - PATIENT HAD INTER-OPERATION GLENOID FIX. HEMI ADAPTER AND HEMI HEAD WAS USED AFTER BONE GRAFTING. CAME BACK FOR REVISION. ZIMMER BIOMET AUGMENTED GLENOID WAS USED WITH DJO 36MM LINER.

  Patient problems: Insufficient Information

  MAUDE report 11996819 ↗
• InjuryFeb 11, 2020Fracture; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - A PREVIOUS HEMI SHOULDER FOR FRACTURE WAS CONVERTED TO A REVERSE.

  Patient problems: No Information

  MAUDE report 9694123 ↗
• InjuryDec 19, 2019Positioning Problem

  REVISION SURGERY - PATIENT COMPLAINED OF DISCOMFORT AND LOSS OF RANGE OF MOTION.

  Patient problems: Discomfort; Failure of Implant; Loss of Range of Motion

  MAUDE report 9495227 ↗
• InjuryJan 31, 2018Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO THE PATIENT NOT HAVING ENOUGH GLENOID BONE TO DO A REVERSE DURING THE PRIMARY SURGERY, SO THE SURGEON PUT A HEMI IN. THE REVISION SURGERY WAS PLANNED TO GIVE TIME FOR THE BONE GRAFT TO TAKE TO THE GLENOID. THIS WAS NOT A CASE OF IMPLANT FAILURE.

  Patient problems: No Code Available

  MAUDE report 7231256 ↗
• InjuryJan 22, 2018Fracture

  REVISION SURGERY - THE REPRESENTATIVE INDICATED THAT THE ORIGINAL CASE WAS DUE TO THE PATIENT'S GLENOID FRACTURING INTRA-OPERATIVELY AND USED A HEMI UNTIL THE GLENOID HEALED. THE SURGEON REMOVED THE HEMI ADAPTER AND THE 46 HEAD AND CONVERTED TO A REVERSE AS THIS WAS THE INITIAL PLAN TO THE SURGERY.

  Patient problems: Bone Fracture(s); Failure of Implant; No Code Available

  MAUDE report 7209629 ↗
• InjuryFeb 10, 2017Insufficient Device Problem Information

  REVISION SURGERY - THE ITEMS REPORTED ON THIS COMPLAINT WERE FIRST IMPLANTED ON (B)(6) 2016 WHEN AN INFECTED BIOMET REVERSE SHOULDER WAS REMOVED. THEY WERE IMPLANTED USING ANTIBIOTIC CEMENT TO HEAL THE INFECTION KNOWING THAT ONCE IT WAS HEALED, THE SURGEON WOULD REMOVE THESE ITEMS AND IMPLANT A DJO ALTIVATE REVERSE.

  Patient problems: Unspecified Infection

  MAUDE report 6322062 ↗
• InjuryApr 5, 2016Device Operates Differently Than Expected

  REVISION SURGERY - DUE TO A FAILED ROTATOR CUFF OF A HEMI ARTHROPLASTY FOR FRACTURE.

  Patient problems: No Code Available

  MAUDE report 5547364 ↗