DJO SURGICAL 520-46-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888912145152), received between Jun 22, 2017 and Oct 4, 2023 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - MDR - 2ND STAGE REVISION SURGERY/REQUIRED INTERVENTION TO PREVENT IMPAIRMENT/DAMAGE.

  Patient problems: Insufficient Information

  MAUDE report 17874007 ↗
• InjuryMay 25, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO PRODUCT FAILURE.

  Patient problems: Failure of Implant

  MAUDE report 14497960 ↗
• InjuryMar 29, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - THE ORIGINAL PROCEDURE WAS A HEMI FOR FRACTURE. THE SUN SCAP FAILED AND SO THE CASE WAS REVISED AND CONVERTED TO A REVERSE.

  Patient problems: Insufficient Information

  MAUDE report 13942524 ↗
• InjurySep 23, 2021Unstable; Naturally Worn; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - THE LIMA POLY ON THE GLENOID SIDE BECAME WORN DOWN AND LED TO SHOULDER BECOMING UNSTABLE.

  Patient problems: Insufficient Information

  MAUDE report 12519951 ↗
• InjuryJun 16, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - THE PATIENT HAD FALLEN AND TORN HER ROTATOR CUFF, SHE HAD ALSO LOOSENED THE GLENOID IMPLANT. SURGEON REMOVED THE TURON HEAD, HEMI ADAPTER AND GLENOID. HE TRANSITIONED TO A REVERSE TOTAL SHOULDER.

  Patient problems: Fall

  MAUDE report 12012168 ↗
• InjuryNov 6, 2019Unexpected Therapeutic Results

  REVISION SURGERY - PATIENT HAD A CEMENTED HEMI-ARTHROPLASTY THAT FAILED AND SURGEON REVISED HIM TO A REVERSE.

  Patient problems: Failure of Implant

  MAUDE report 9285995 ↗
• InjuryApr 30, 2018Device Dislodged or Dislocated

  SECOND REVISION SURGERY - DUE TO THE PATIENT HAVING DISLOCATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7473720 ↗
• InjuryMar 5, 2018Device Operates Differently Than Expected

  REVISION SURGERY - DUE TO A FAILED HEMI.

  Patient problems: No Code Available

  MAUDE report 7314768 ↗
• InjuryJul 12, 2017Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO THE PATIENT HAVING SOFT TISSUE ISSUES.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 6706068 ↗
• InjuryJun 22, 2017Inadequacy of Device Shape and/or Size

  REVISION SURGERY - DUE TO THE PATIENT TEARING THEIR SUBSCAP; A SMALLER HEAD SIZE WAS NEEDED.

  Patient problems: Excessive Tear Production

  MAUDE report 6662075 ↗

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-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-0798-2011 · Nov 5, 2010 · Terminated
  Turon Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical
• Z-0799-2011 · Nov 5, 2010 · Terminated
  Turon Shoulder System Instrumentation, Turon Trial Humeral Neck, DJO Surgical