DJO SURGICAL 506-00-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888912024396), received between Jan 15, 2016 and Nov 4, 2025 — classified as 15 injuries.

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

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2025Unstable; Unstable

  REVISION SURGERY - DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 23472373 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 19726860 ↗
• InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO LOOSENING.

  Patient problems: Joint Laxity

  MAUDE report 19621229 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - REQUIRED INTERVENTION TO PREVENT IMPAIRMENT/DAMAGE.

  Patient problems: Fall

  MAUDE report 16342825 ↗
• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - PATIENT HAD A DISTAL FRACTURE ON THE HUMERUS. TO REVISE SURGEON REMOVED THE 36 POLY AND CONVERSION SHELL AS WELL AS THE STEM.

  Patient problems: Bone Fracture(s)

  MAUDE report 15873578 ↗
• InjurySep 8, 2021Loose or Intermittent Connection

  REVISION SURGERY - DUE TO LOOSE STEM.

  Patient problems: Insufficient Information

  MAUDE report 12439739 ↗
• InjuryJul 30, 2018Unstable; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO INSTABILITY. THE PATIENT PREVIOUSLY HAD A REVERSE DONE AND CAME TO SEE REVISION SURGEON TO HELP STABILIZE. THE PREVIOUS SURGEON DID NOT HAVE IMPLANTS IN CORRECT POSITION. THE SURGEON WAS UNABLE TO DO 2ND REVERSE BECAUSE OF SUBSCAPULARIS FAILURE, INSTABILITY.

  Patient problems: No Code Available

  MAUDE report 7732666 ↗
• InjuryJan 22, 2018Device Slipped

  REVISION SURGERY - DUE TO THE TAPER DISENGAGING AND THE STEM BEING LOOSE AS WELL.

  Patient problems: No Code Available

  MAUDE report 7209807 ↗
• InjuryOct 24, 2017Loose or Intermittent Connection

  REVISION SURGERY - DUE TO THE PATIENT EXPERIENCING PAIN. THE STEM WAS LOOSE; THE SURGEON REMOVED EVERYTHING EXCEPT FOR THE BASEPLATE AND ONE SIZE 18MM SCREW.

  Patient problems: Pain

  MAUDE report 6974564 ↗
• InjuryOct 4, 2017Insufficient Device Problem Information

  REVISION SURGERY - DUE TO THE SURGEON HAVING INDICATED THAT THE STEM WAS LOOSE AND NEEDED TO BE REMOVED. OUR REPRESENTATIVE WAS TOLD THE ORIGINAL SURGERY WAS DONE ABOUT 5 YEARS AGO AND NO OTHER PATIENT INFORMATION WAS GIVEN REGARDING IT.

  Patient problems: No Code Available

  MAUDE report 6914300 ↗
• InjuryJul 20, 2017Detachment of Device or Device Component

  REVISION SURGERY - DUE TO THE SHELL DISASSOCIATING FROM THE STEM ON THE HUMERAL SIDE.

  Patient problems: No Code Available

  MAUDE report 6730528 ↗
• InjuryMar 16, 2017Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO THE PATIENT DEVELOPING AN INFECTION THE REVERSE SHOULDER PROSTHESIS (RSP) PRIMARY COMPONENTS WERE REMOVED AND A TEMPORARY ANTIBIOTIC SPACER WAS PLACED IN. SUBSEQUENTLY, A REVERSE SHOULDER WAS PLACED UPON THE HEALING OF THE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6411299 ↗
• InjuryApr 5, 2016Material Separation; Device Operates Differently Than Expected

  REVISION SURGERY - DUE TO PRODUCT FAILURE; THE MORSE TAPER BETWEEN SHELL AND STEM DISASSOCIATED.

  Patient problems: No Code Available

  MAUDE report 5548480 ↗
• InjuryMar 1, 2016Fracture

  REVISION SURGERY - DUE TO THE PATIENT SUFFERING A FRACTURE AND A SUSPECTED INFECTION.

  Patient problems: No Code Available

  MAUDE report 5472053 ↗
• InjuryJan 15, 2016Device Slipped

  REVISION SURGERY - DUE TO THE HUMERAL STEM BECOMING LOOSE POST OPERATIVE. THE SURGEON REMOVED ALL OF THE COMPONENTS AND REPLACED THEM WITH A HEMI ARTHROPLASTY.

  Patient problems: No Code Available

  MAUDE report 5370530 ↗

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