DJO SURGICAL 520-10-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00190446176015), received between Aug 13, 2019 and May 24, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

6 other recalls cover devices cleared under the same FDA submission (K162024); 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. How this data works · Data updated Oct 13, 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.

• InjuryMay 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO ANATOMIC EXPLANTED AND REVERSE IMPLANTED, REASON UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22082397 ↗
• InjuryOct 4, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INSTABILITY AND PAIN.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 20378169 ↗
• InjuryMay 19, 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 16969436 ↗
• InjuryJun 9, 2022Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY - PATIENT PRESENTED WITH PAIN AND LACK OF MOTION IN THE RIGHT SHOULDER. A DIAGNOSTIC ARTHROSCOPY WAS PERFORMED DURING WHICH THE GLENOID COMPONENT WAS NOTED TO BE LOOSE. CULTURES WERE TAKEN AND GREW OUT P.ACNE AND THE FIRST STAGE REVISION TO REMOVE THE COMPONENTS .

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 14646030 ↗
• InjuryFeb 17, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - SUBSCAP ON THE TOTAL SHOULDER ARTHROPLASTY FAILED AND NEEDED TO CONVERT TO A REVERSE SHOULDER.

  Patient problems: Failure of Implant

  MAUDE report 13548619 ↗
• InjuryDec 20, 2021Device Dislodged or Dislocated

  REVISION SURGERY : DUE TO DISLOCATION OF SHOULDER CAUSING THE NEED FOR A FULL REVISION.

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

  MAUDE report 13046944 ↗
• InjuryDec 14, 2021Fracture; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - LACK OF MOTION DUE TO PREVIOUS FRACTURE CAUSING BONE SPURS.

  Patient problems: Insufficient Information

  MAUDE report 13002031 ↗
• InjuryNov 13, 2020Therapeutic or Diagnostic Output Failure

  REVISION SURGERY - DUE TO PATIENT CONVERTED TO REVERSE DUE TO SUBSCAPULARIS FAILURE.

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

  MAUDE report 10838721 ↗
• InjuryJun 3, 2020Unstable; Device Dislodged or Dislocated

  REVISION SURGERY - PATIENT WAS UNSTABLE AND DISLOCATED.

  Patient problems: No Code Available

  MAUDE report 10114742 ↗
• InjuryJan 28, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO PATIENT COMPLAINING OF PAIN.

  Patient problems: Pain

  MAUDE report 9638090 ↗
• InjuryAug 13, 2019Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY: DUE TO FAILURE OF SUBSCAPULARIS HEALING, CAUSING PAIN. ORIGINAL SURGERY WAS A HEMI-ARTHROPLASTY FOR AVASCULAR NECROSIS.

  Patient problems: Impaired Healing; Pain

  MAUDE report 8889379 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162024. One submission often covers many models, so check the product and lot details in each record.

• Z-2331-2021 · Jun 28, 2021 · Open, Classified
  AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-
• Z-1259-2018 · Jan 29, 2018 · Completed
  Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as
• Z-1256-2018 · Jan 29, 2018 · Completed
  Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as
• Z-1260-2018 · Jan 29, 2018 · Completed
  Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated
• Z-1257-2018 · Jan 29, 2018 · Completed
  Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as
• Z-1258-2018 · Jan 29, 2018 · Completed
  Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as