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DJO SURGICAL 508-40-103Recalls & reported problems

Encore Medical, L.P. · GLENOID, HEAD W/RETAINING SCREW, RSP, 40MM/-4MM · Class 2 · Implant

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

Adverse event reports
7
Deaths reported
0
Injuries reported
7
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888912144513), received between May 10, 2017 and Jul 13, 2024 — classified as 7 injuries.

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

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem4
  • Appropriate Device Problem Term/Code Not Available1
  • Device Dislodged or Dislocated1
  • Insufficient Device Problem Information1

Patient problems

  • Joint Dislocation2
  • No Code Available2
  • Unspecified Infection2
  • Fall1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    RIVISION SURGERY - DUE TO DISLOCATION.

    Patient problems: Joint Dislocation

    MAUDE report 19736586 ↗
  • InjuryFeb 8, 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 18673476 ↗
  • InjuryApr 5, 2023Adverse 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 16686460 ↗
  • InjuryDec 6, 2020Insufficient Device Problem Information

    4TH REVISION SURGERY - DUE TO MULTIPLE FALLS.

    Patient problems: Fall

    MAUDE report 10955777 ↗
  • InjuryJan 8, 2018Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY - DUE TO THE PATIENT BEING UNSTABLE AND DISLOCATING. THE PATIENT HAD A REVISION DONE, BUT THE ORIGINAL SURGERY HAD ANOTHER BRAND OF IMPLANTS TAKEN OUT AND DJO PRODUCTS PUT IN. WHILE IN THE HOSPITAL, THE PATIENT WAS UNSTABLE AND DISLOCATED SO ANOTHER REVISION WAS DONE TO REPLACE THE GLENOID HEAD WITH SCREW AND NEW INSERT.

    Patient problems: Joint Dislocation

    MAUDE report 7172286 ↗
  • InjurySep 29, 2017Device Dislodged or Dislocated

    REVISION SURGERY - DUE TO THE PATIENT CONTINUING TO DISLOCATE AFTER MULTIPLE REVISIONS. THE SURGEON TOOK OUT THE BASELATE AND GLENOSPHERE AND CONVERTED TO A HEMI.

    Patient problems: No Code Available

    MAUDE report 6906328 ↗
  • InjuryMay 10, 2017Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY - STAGE ONE WAS 6 MONTHS AGO; EXPLANTED PART 508-40-103.

    Patient problems: No Code Available

    MAUDE report 6559023 ↗

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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