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DJO SURGICAL 508-01-444Recalls & reported problems

Encore Medical, L.P. · RSP HUM SOCKET INSERT, 44M +4MM, SEMI · Class 2 · Implant

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

Adverse event reports
5
Deaths reported
0
Injuries reported
5
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888912144315), received between Dec 8, 2017 and Sep 11, 2023 — classified as 5 injuries.

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

1 other recall cover devices cleared under the same FDA submission (K100741); 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

  • Adverse Event Without Identified Device or Use Problem2
  • Appropriate Device Problem Term/Code Not Available2
  • Device Dislodged or Dislocated2
  • Use of Device Problem1

Patient problems

  • Joint Dislocation2
  • No Known Impact Or Consequence To Patient1
  • Pain1
  • Unspecified Infection1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY - DUE TO DISLOCATION.

    Patient problems: Joint Dislocation

    MAUDE report 17726684 ↗
  • InjuryApr 12, 2022Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY - PATIENT WAS DISLOCATING, SO SURGEON REVISED HIM WITH A THICKER POLY.

    Patient problems: Joint Dislocation

    MAUDE report 14086018 ↗
  • InjuryNov 25, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY - PATIENT WAS PAINFUL AND A CHRONIC DISLOCATOR. REPLACED 44MM +4MM INSERT WITH AN 8MM SPACER AND A 44MM +4MM SEMI-CONSTRAINED INSERT.

    Patient problems: Pain

    MAUDE report 10906801 ↗
  • InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem

    SECOND REVISION SURGERY - PATIENT IS 2.5 YEARS POST-OPERATION AND PRESENTED WITH POSSIBLE INFECTION. SURGEON OPTED TO REVISE AND REMOVE ALL EXISTING IMPLANTS.

    Patient problems: Unspecified Infection

    MAUDE report 8804790 ↗
  • InjuryDec 8, 2017Use of Device Problem; Device Dislodged or Dislocated

    THIRD REVISION SURGERY - DUE TO THE PATIENT HAVING DISLOCATED. SHE WAS NON-COMPLIANT WITH POST OPERATION CARE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7100707 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100741. One submission often covers many models, so check the product and lot details in each record.

  • Z-1458-2026 · Jan 15, 2026 · Open, Classified
    Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432

Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices

All PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page