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DJO SURGICAL 508-00-040Recalls & reported problems

Encore Medical, L.P. · SOCKET, INSERT 40MM STD. RSP HUMERAL · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
9
Deaths reported
0
Injuries reported
9
Recalls naming it
0

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888912144193), received between Sep 22, 2015 and Nov 14, 2022 — classified as 9 injuries.

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

Device problems

  • Appropriate Device Problem Term/Code Not Available4
  • Adverse Event Without Identified Device or Use Problem2
  • Device Dislodged or Dislocated2
  • Unstable2

Patient problems

  • No Code Available3
  • Pain2
  • Unspecified Infection2
  • Insufficient Information1
  • Joint Dislocation1
  • Medical device site infection1

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY - PATIENT WAS INFECTED. WASHED OUT, CHANGE THE CUP, LINER AND HEAD.

    Patient problems: Medical device site infection

    MAUDE report 15794285 ↗
  • InjuryNov 7, 2021Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY - DUE TO WASHOUT, POLY WAS SWAPPED.

    Patient problems: Insufficient Information

    MAUDE report 12762239 ↗
  • InjurySep 17, 2020Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY - PATIENT HAS PROBABLE INFECTION.

    Patient problems: Unspecified Infection

    MAUDE report 10547476 ↗
  • InjurySep 1, 2020Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY - DUE TO AN INFECTION.

    Patient problems: Unspecified Infection

    MAUDE report 10476880 ↗
  • InjuryNov 8, 2019Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY - PATIENT COMPLAINED OF PAIN, POSSIBLE INFECTION.

    Patient problems: Pain

    MAUDE report 9295965 ↗
  • InjuryDec 26, 2017Unstable; Device Dislodged or Dislocated

    REVISION SURGERY - DUE TO THE PATIENT BEING CHRONICALLY UNSTABLE AND SOMETIMES DISLOCATING. THE SURGEON PUT IN A BIGGER LINER AND GLENOID HEAD. THIS IS A REVISION OF A PREVIOUS REVISION SURGERY.

    Patient problems: Joint Dislocation; No Code Available

    MAUDE report 7146329 ↗
  • InjuryDec 6, 2017Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY - DUE TO THE PATIENT COMPLAINING OF POSTERIOR PAIN. THE SURGEON FOUND THAT THE PATIENT'S X-RAYS, COMPUTERIZED AXIAL TOMOGRAPHY (CAT) SCANS AND MAGNETIC RESONANCE IMAGING (MRI) LOOKED GOOD. THE SURGEON DID THE REVISION AND INDICATED THE IMPLANTS LOOKED FINE TOO. HE DID NOT KNOW WHY THE PATIENT WAS FEELING PAIN AND DIDN'T THINK ANYTHING WOULD CHANGE AFTER THE REVISION SURGERY.

    Patient problems: Pain

    MAUDE report 7087167 ↗
  • InjuryDec 5, 2017Unstable

    REVISION SURGERY - DUE TO THE PATIENT EXPERIENCING JOINT INSTABILITY. THE SURGEON DETERMINED THAT A LARGER IMPLANT WAS THE BEST POSSIBLE OPTION.

    Patient problems: No Code Available

    MAUDE report 7084225 ↗
  • InjurySep 22, 2015Device Dislodged or Dislocated

    REVISION SURGERY - DUE TO THE PATIENT'S SHOULDER DISLOCATING.

    Patient problems: No Code Available

    MAUDE report 5095516 ↗

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

Other shoulder prosthesis, reverse configuration devices

All shoulder prosthesis, reverse configuration devices →

Sources and updates

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