DJO SURGICAL 520-46-016Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00888912145145), received between Jan 5, 2017 and Jul 2, 2025 — classified as 16 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K080402); 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 22391024 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 21648731 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 16820445 ↗
• InjurySep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - PATIENT HAD A HEMI SHOULDER DONE, PATIENT'S SHOULDER WAS UNSTABLE, HEMI SHOULDER WAS CONVERTED TO A REVERSE SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 15477642 ↗
• InjuryMay 7, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DISLOCATION OF HUMERAL HEAD FROM GLENOID.

  Patient problems: Joint Dislocation

  MAUDE report 14317693 ↗
• InjuryJan 7, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - HEAD DISLODGED, NOT SURE HOW. PATIENT WAS DISLOCATED.

  Patient problems: Insufficient Information

  MAUDE report 13198897 ↗
• InjuryNov 10, 2020Therapeutic or Diagnostic Output Failure

  REVISION SURGERY - PATIENT HAD A TURON TOTAL SHOULDER IMPLANTED APPROXIMATELY 10 YEARS AGO. THE PATIENT HAD SUBSCAP FAILURE AND NEEDED TO HAVE A REVERSE TSA.

  Patient problems: No Code Available

  MAUDE report 10815849 ↗
• InjuryJul 6, 2020Naturally Worn

  REVISION SURGERY - PATIENT DEVELOPED SIGNIFICANT GLENOID WEAR, AND NEEDED TO BE RESURFACED. THE PARTS LISTED WERE REMOVED TO ALLOW ACCESS TO THE GLENOID SINCE THE PRIMARY SURGERY WAS A HEMI ARTHROPLASTY.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10234339 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - SURGEON WANTED TO REDUCE SIZE OF HEAD DUE TO PATIENT COMPLAINT OF PAIN. WE WERE NOT INFORMED OF CASE DUE TO SURGEON THOUGHT IT WAS BIOMET SYSTEM AND ONLY DISCOVERED IT WAS DJO SYSTEM UNTIL HE OPENED THE PATIENT UP AND POPPED THE HEAD OFF.

  Patient problems: Pain

  MAUDE report 9729348 ↗
• InjuryAug 2, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8855484 ↗
• InjuryMar 20, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO THE PATIENT COMPLAINING OF STIFFNESS.

  Patient problems: Muscular Rigidity

  MAUDE report 8437305 ↗
• InjuryAug 3, 2018Loose or Intermittent Connection

  REVISION SURGERY - DUE TO PAIN. THE PATIENT HAD CONTINUED PAIN AFTER THE ORIGINAL SURGERY. NEW SURGEON SCOPED HIM IN 2017, GLENOID WAS LOSE, REMOVED ARTHROSCOPICALLY. THE SURGEON REVISED THE PATIENT, REMOVING HEAD, NECK, AND LEAVING STEM. HE DID AN EXACTECH REVERSE GLENOID, CONVERSION HUMERAL SHELL DJO PLUS POLY. THE 21 DAY CULTURES SENT, TISSUE LOOKED QUESTIONABLE.

  Patient problems: Pain

  MAUDE report 7748635 ↗
• InjuryFeb 13, 2018Device Operates Differently Than Expected

  REVISION SURGERY - DUE TO THE PATIENT HAVING A ROTATOR CUFF FAILURE.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7266714 ↗
• InjuryMay 15, 2017Patient-Device Incompatibility

  REVISION SURGERY - DUE TO THE SURGEON CONVERTING FROM A HEMI TO REVERSE SHOULDER.

  Patient problems: Failure of Implant

  MAUDE report 6567614 ↗
• InjuryApr 26, 2017Inadequacy of Device Shape and/or Size

  REVISION SURGERY - OVERSTUFFING OF THE JOINT DUE TO TOO LARGE OF A HUMERAL HEAD. THE PATIENT WAS SUFFERING FROM PAIN AND DISCOMFORT.

  Patient problems: Discomfort; Pain

  MAUDE report 6522697 ↗
• InjuryJan 5, 2017Torn Material

  REVISION SURGERY - DUE TO THE PATIENT HAVING A ROTATOR CUFF TEAR AND HAVING TO BE CONVERTED TO A REVERSE SHOULDER.

  Patient problems: No Code Available

  MAUDE report 6227285 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080402. One submission often covers many models, so check the product and lot details in each record.

• Z-0798-2011 · Nov 5, 2010 · Terminated
  Turon Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical
• Z-0801-2011 · Nov 5, 2010 · Terminated
  Turon Shoulder System Instrumentation, Turon Pegged Glenoid Drill Guide, REF 804-25-024, DJO Surgical
• Z-0800-2011 · Nov 5, 2010 · Terminated
  Turon Shoulder System Instrumentation, Turon Trial Pegged Glenoid, DJO Surgical
• Z-0799-2011 · Nov 5, 2010 · Terminated
  Turon Shoulder System Instrumentation, Turon Trial Humeral Neck, DJO Surgical