DJO SURGICAL 520-46-116Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888912025034), received between Oct 3, 2016 and Feb 8, 2024 — classified as 12 injuries.

The most frequently reported specific device problem is “Degraded” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 8, 2024Adverse 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 18673477 ↗
• InjurySep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO PAIN.

  Patient problems: Implant Pain

  MAUDE report 17796046 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO DISLOCATION & INSTABILITY.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 17741736 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 17176091 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY- TURON PEGGED GLENOID, PATIENT COMPLAINED OF PAIN. ONLY INFORMATION AVAILABLE ON ORIGINAL SURGERY WAS THAT IT WAS PERFORMED IN 2016 IN FLORIDA.

  Patient problems: Pain

  MAUDE report 14701532 ↗
• InjuryMay 10, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - PATIENT PRESENTED POST OPERATION TOTAL SHOULDER COMPLAINING OF PAIN. SURGEON DETERMINED A REVISION TO A REVERSE SHOULDER TO CORRECT ROTATOR CUFF INSTABILITY.

  Patient problems: Pain

  MAUDE report 14346373 ↗
• InjuryJan 23, 2020Device Dislodged or Dislocated

  REVISION SURGERY - DUE TO DISLOCATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9623117 ↗
• InjuryDec 12, 2017Insufficient Device Problem Information

  REVISION SURGERY - DUE TO THE PATIENT HAVING ROTATOR CUP DEFICIENCY.

  Patient problems: No Code Available

  MAUDE report 7109654 ↗
• InjuryDec 1, 2017Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO THE PATIENT'S TURON ANATOMIC SHOULDER BEING REVISED TO A REVERSE TOTAL SHOULDER. THE SURGEON ATTEMPTED TO CONVERT WITH CONVERSION MODULES, BUT WAS UNABLE TO DO SO. ALTIVATE REVERSE SHOULDER PROSTHESIS (RSP) WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Code Available

  MAUDE report 7075211 ↗
• InjuryMay 5, 2017Device Operates Differently Than Expected

  REVISION SURGERY - DUE TO A FAILED ROTATOR CUFF POST OPERATION. THE SURGEON PERFORMED A TURON CONVERSION TO A REVERSE SHOULDER PROSTHESIS (RSP).

  Patient problems: No Code Available

  MAUDE report 6549698 ↗
• InjuryMar 16, 2017Unstable

  REVISION SURGERY - THE PATIENT ORIGINALLY HAD A TURON TOTAL IMPLANTED. THE PATIENT WAS FEELING SOME PAIN AND INSTABILITY; THE SURGEON REMOVED ALL OF THE COMPONENTS AND PUT IN A REVERSE.

  Patient problems: Pain

  MAUDE report 6411106 ↗
• InjuryOct 3, 2016Degraded

  REVISION SURGERY - DUE TO GLENOID DETERIORATION.

  Patient problems: No Code Available

  MAUDE report 5995074 ↗

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-0800-2011 · Nov 5, 2010 · Terminated
  Turon Shoulder System Instrumentation, Turon Trial Pegged Glenoid, 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-0799-2011 · Nov 5, 2010 · Terminated
  Turon Shoulder System Instrumentation, Turon Trial Humeral Neck, DJO Surgical