DJO SURGICAL 508-03-436Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00190446256977), received between Nov 4, 2020 and Sep 23, 2021 — classified as 2 injuries.

3 other recalls cover devices cleared under the same FDA submission (K172351); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2021Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - THE PATIENT WAS INFECTED, THE SURGEON REMOVED ALL OF THE HARDWARE IN THE PATIENT. HE USED OUR STEM, HEMI ADAPTER, AND ANATOMIC HEAD TO CREATE A SPACER. HE WRAPPED THE SPACER WITH ANTIBIOTIC INFUSED CEMENT AND PLACED IT IN THE PATIENT.

  Patient problems: Unspecified Infection

  MAUDE report 12519960 ↗
• InjuryNov 4, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - THE REVERSE SHOULDER WAS DONE WITH ANOTHER DJO VENDOR OUT IN (B)(6). PATIENT HAD PAIN AND NUMBNESS. SURGEON REMOVED AND REPLACED THE 36MM SMALL SHELL +4 SEMI CONSTRAINED INSERT AND REPLACED WITH A 36MM SEMI CONSTRAINED INSERT.

  Patient problems: Numbness; Pain

  MAUDE report 10784310 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172351. One submission often covers many models, so check the product and lot details in each record.

• Z-0281-2024 · Sep 25, 2023 · Open, Classified
  RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.
• Z-2607-2023 · Aug 4, 2023 · Open, Classified
  DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108
• Z-0117-2021 · Aug 31, 2020 · Terminated
  AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of