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DJO SURGICAL 508-00-440Recalls & reported problems

Encore Medical, L.P. · RSP HUM SOCKET INSERT 40MM +4MM, STANDARD · Class 2 · Implant

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

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888912144223), received between Dec 22, 2016 and Jul 19, 2017 — classified as 3 injuries.

The most frequently reported specific device problem is “Unstable” (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

  • Unstable2
  • Use of Device Problem1

Patient problems

  • No Code Available3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 19, 2017Use of Device Problem

    REVISION SURGERY. THIS WAS A SCHEDULED TWO STAGE REVISION. DURING THE FIRST SURGERY THE SURGEON USED A LARGE AMOUNT OF BONE GRAFT IN THE GLENOID, THE SURGEON THOUGHT IT WAS BEST TO LEAVE THE GLENOSPHERE OFF SO THE BONE GRAFT COULD HEAL. THE GRAFT HEALED AND THIS SURGERY WAS TO PLACE THE GLENOSPHERE AND REPLACE THE INSERT.

    Patient problems: No Code Available

    MAUDE report 6725373 ↗
  • InjuryJan 7, 2017Unstable

    REVISION SURGERY - DUE TO THE PATIENT HAVING INSTABILITY.

    Patient problems: No Code Available

    MAUDE report 6231853 ↗
  • InjuryDec 22, 2016Unstable

    REVISION SURGERY - THE PATIENT'S ORIGINAL SURGERY (B)(4) TOOK PLACE ON (B)(6) 2014. ANOTHER (B)(4) TOOK PLACE ON (B)(6) 2014. ANOTHER REVISION (B)(4) TOOK PLACE ON (B)(6) 2015. THE LAST SURGERY TOOK PLACE ON (B)(6) 2016. ALL REVISIONS TOOK PLACE BECAUSE THE PATIENT WAS UNSTABLE AND THE SURGEON KEPT INCREASING THE GLENOID SIZE IN ORDER TO TRY TO MAKE THE JOINT STABLE. HE WAS UNSUCCESSFUL, THUS REMOVING ALL (B)(4) IMPLANTS, ACCORDING TO THE REPRESENTATIVE.

    Patient problems: No Code Available

    MAUDE report 6201596 ↗

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

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