DJO SURGICAL 506-00-012Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888912024402), received between Sep 3, 2015 and Sep 20, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Slipped” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K051075); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - PATIENT FELL AND HAD A PERI PROSTHETIC FRACTURE IMPLANTS REMOVED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 12500425 ↗
• InjuryMay 24, 2016Therapeutic or Diagnostic Output Failure

  REVISION SURGERY - DUE TO THE HUMERAL STEM SPINNING OUT AND THE BONE HAVING BOWED.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 5676820 ↗
• InjuryMar 24, 2016Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO LOOSENING OF THE HUMERAL STEM FROM PREVIOUS FRACTURE REPAIR. THE SURGEON REMOVED AND PUT IN A SIZE 12 REVISION STEM AND SIZE 40 HEAD. HE ALSO IMPLANTED A SIZE 40 SOCKET SHELL INSERT AND NEUTRAL SOCKET SHELL.

  Patient problems: Failure of Implant

  MAUDE report 5523021 ↗
• InjuryFeb 29, 2016Device Slipped

  SECOND REVISION SURGERY - DUE TO BONE LOSS IN THE HUMERUS CONTRIBUTING TO THE LOOSENING OF THE HUMERAL STEM. SEE (B)(4).

  Patient problems: Osteolysis

  MAUDE report 5468477 ↗
• InjurySep 3, 2015Fracture

  REVISION SURGERY: THE PATIENT FELL ON THEIR SHOULDER AND FRACTURED THEIR GLENOID. THE SURGEON REMOVED ALL OF THE ORIGINAL IMPLANTS AND REPLACED THEM WITH NEW IMPLANTS.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 5054251 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051075. One submission often covers many models, so check the product and lot details in each record.

• Z-1460-2026 · Jan 15, 2026 · Open, Classified
  Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
• Z-0625-2024 · Oct 5, 2023 · Completed
  Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
• Z-0282-2024 · Sep 25, 2023 · Open, Classified
  RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
• Z-2606-2023 · Aug 4, 2023 · Open, Classified
  DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm, REF: 508-32-104; Reverse Shoulder Syst
• Z-2739-2011 · Apr 18, 2011 · Terminated
  Reverse Shoulder Prosthesis System RSP Humeral Socket Shell DJO 9800 Metric Blvd. Austin, TX 78758 STERILE R Model numbers: 508-00-000 and 508-00-008. The Reverse Shoulder Prost