DJO SURGICAL 507-08-175Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888912144087), received between Apr 12, 2018 and Oct 4, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K041066); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2018Loose or Intermittent Connection

  REVISION SURGERY - DUE TO THE STEM BEING LOOSE AND CAUSING PAIN. THE SURGEON REMOVED THE STEM, CUP AND LINER AS WELL AS THE ORIGINAL GLENOSPHERE. HE REMOVED THE CEMENT MANTEL AND REPLACED WITH A SIZE 12 PRIMARY MONOBLOCK CEMENTED STEM. REPLACED THE 36 NEUTRAL GLENOSPHERE WITH A 32 NEUTRAL FOR MORE OFFSET AND BUILT THE POLY TO A +12.

  Patient problems: Pain

  MAUDE report 7935055 ↗
• InjuryApr 12, 2018Unstable; Naturally Worn

  SECOND REVISION SURGERY - DUE TO WEAR AND INSTABILITY.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7424737 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041066. One submission often covers many models, so check the product and lot details in each record.

• Z-0098-2024 · Aug 22, 2023 · Open, Classified
  REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
• Z-0184-2008 · Aug 8, 2007 · Terminated
  Encore Reverse Shoulder Prosthesis (RSP) System, Standard Size 36 RSP Humeral Socket Insert; Catalog #: 508-00-036; Sterile; Manufactured by Encore, Medical, L.P., Austin, TX 7875
• Z-0185-2008 · Aug 8, 2007 · Terminated
  Encore Reverse Shoulder Prosthesis (RSP) System, Standard Size 40 RSP Humeral Socket Insert; Catalog #: 508-00-040; Sterile; Manufactured by Encore, Medical, L.P., Austin, TX 7875
• Z-1566-05 · Jul 28, 2005 · Terminated
  Encore Reverse Shoulder Prosthesis (RSP), manufactured and distributed by Encore Medical, L.P. 9800 Metric Blvd., Austin, Texas 78758