DJO SURGICAL 506-00-006Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888912024372), received between Sep 4, 2015 and May 27, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (7 reports).

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Unstable

  REVISION SURGERY DUE TO LOOSENING.

  Patient problems: Joint Laxity

  MAUDE report 25311003 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO IMPLANTS BECAME LOOSE OVER THE YEARS. REMOVED ALL ORIGINAL IMPLANTS.

  Patient problems: Joint Laxity

  MAUDE report 23444155 ↗
• InjuryNov 16, 2021Fracture; Device Dislodged or Dislocated

  REVISION SURGERY - PATIENT HAD PERI-PROSTHETIC FRACTURE AND WAS DISLOCATED.

  Patient problems: Insufficient Information

  MAUDE report 12823872 ↗
• InjuryOct 29, 2019Device Slipped

  REVISION SURGERY - DUE TO POSSIBLE INFECTION AND LOOSE STEM.

  Patient problems: Unspecified Infection

  MAUDE report 9249626 ↗
• InjuryJul 19, 2019Fracture; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - PATIENT HAD A PERI-PROSTHETIC FRACTURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8809404 ↗
• InjuryJan 4, 2019Device Dislodged or Dislocated

  REVISION SURGERY - DUE TO DISLOCATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8219772 ↗
• InjuryNov 30, 2018Loose or Intermittent Connection

  REVISION SURGERY - DUE TO THE STEM BECOMING LOOSE.

  Patient problems: Failure of Implant

  MAUDE report 8120483 ↗
• InjuryJun 13, 2018Loose or Intermittent Connection

  REVISION SURGERY - DUE TO A LOOSE STEM CAUSED FROM CEMENT FAILURE TO FIXATE TO BONE.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7598262 ↗
• InjuryMay 4, 2018Loose or Intermittent Connection

  REVISION SURGERY - DUE TO THE STEM LOOSENING.

  Patient problems: No Code Available

  MAUDE report 7488817 ↗
• InjuryFeb 13, 2018Fracture

  REVISION SURGERY - DUE TO THE PATIENT NEEDING A LONG REVERSE STEM. STEM BROKE DUE TO A FRACTURE.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 7267866 ↗
• InjuryJan 8, 2018Loose or Intermittent Connection

  REVISION SURGERY - DUE TO THE STEM LOOSENING OVER TIME.

  Patient problems: No Information

  MAUDE report 7173284 ↗
• InjuryOct 3, 2017Loose or Intermittent Connection

  REVISION SURGERY - DUE TO THE STEM BEING CEMENTED IN AND IT BEING LOOSE.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 6911245 ↗
• InjurySep 11, 2017Break

  REVISION SURGERY - THE SURGEON REMOVED THE STEM AND INSERT. THE PATIENT FELL AND BROKE BONE, FRACTURING THE STEM.

  Patient problems: Fall

  MAUDE report 6855004 ↗
• InjuryJan 6, 2017Loose or Intermittent Connection

  REVISION SURGERY - DUE TO THE NEUTRAL CUP FORM THE ORIGINAL SURGERY COMING LOOSE. THE SURGEON REMOVED ALL OF THE COMPONENTS AFTER ATTEMPTING TO REVISE. HE PUT IN A MONOBLOCK.

  Patient problems: No Code Available

  MAUDE report 6231058 ↗
• InjurySep 4, 2015Loose or Intermittent Connection; Unstable

  REVISION SURGERY - DUE TO THE PATIENT'S HUMERAL COMPONENT LOOSENING. IT WAS CEMENTED INTO PLACE IN THE ORIGINAL SURGERY, BUT HAD SINCE BECOME UNSTABLE AND LOOSE. THE SURGEON REMOVED THE HUMERAL STEM, HUMERAL SOCKET SHELL AND HUMERAL SOCKET INSERT AND REVISED WITH NEW COMPONENTS.

  Patient problems: No Code Available

  MAUDE report 5058312 ↗

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-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-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-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