DJO SURGICAL 520-42-316Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00190446176190), received between Dec 18, 2018 and Jul 28, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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. 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.

• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO GLENOID BONE WEAR AFTER HEMI SHOULDER AND ROTATOR CUFF WEAR.

  Patient problems: Joint Laxity

  MAUDE report 22638381 ↗
• InjuryDec 7, 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 20873932 ↗
• InjuryMay 10, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - FAILED SUB SCAP REPAIR FOR DISLOCATION/INSTABILITY.

  Patient problems: Insufficient Information

  MAUDE report 14346389 ↗
• InjuryAug 10, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - PATIENT IS 20 MONTHS POST OPERATION OF A HEMI SHOULDER FOR AVASCULAR NECROSIS. SURGEON DETERMINED THE GLENOID SHOULD BE RESURFACED. HUMERAL HEAD WAS REMOVED FOR EXPOSURE AND THEN REPLACED.

  Patient problems: Necrosis

  MAUDE report 12301419 ↗
• InjuryNov 23, 2020Device Dislodged or Dislocated; Therapeutic or Diagnostic Output Failure

  REVISION SURGERY: DUE TO SUB SCAPULAR FAILURE AND ANTERIOR DISLOCATION.

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

  MAUDE report 10884826 ↗
• InjuryFeb 12, 2020Device Dislodged or Dislocated

  REVISION SURGERY - PATIENT HAD DISLOCATION. REMOVED THE TOTAL SHOULDER AND DID A RSP.

  Patient problems: Failure of Implant

  MAUDE report 9700541 ↗
• InjuryNov 20, 2019Loose or Intermittent Connection

  REVISION SURGERY - GLENOID BEGIN TO LOOSEN.

  Patient problems: Failure of Implant

  MAUDE report 9349561 ↗
• InjurySep 23, 2019Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - PATIENT HAD DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 9105688 ↗
• InjuryMar 12, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO THE PATIENT COMPLAINING OF PAIN. IMPINGEMENT OF ACROMION.

  Patient problems: Pain

  MAUDE report 8414364 ↗
• InjuryDec 18, 2018Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO IMPINGEMENT. THE SURGEON WENT WITH A SMALLER HEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8176523 ↗

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 # 520-16
• 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-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
• 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