DJO SURGICAL 506-00-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888912024389), received between Sep 23, 2015 and May 16, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 19337933 ↗
• InjuryAug 4, 2022Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY - THE HUMERAL STEM WAS LOOSE. IT LOOKS LIKE THE BONE CEMENT FAILED.

  Patient problems: Failure of Implant

  MAUDE report 15165356 ↗
• InjurySep 9, 2020Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO 1ST GENERATION RSP IMPLANT. STEM AND GLENOSPHERE WERE REVISED.

  Patient problems: No Code Available

  MAUDE report 10511152 ↗
• InjuryApr 8, 2020Fracture; Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - HUMERAL FRACTURE AT DISTAL TIP OF STEM. HUMERAL STEM LOOSENING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9938657 ↗
• InjuryNov 6, 2019Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - THE ORIGINAL REVERSE SHOULDER PROSTHESIS WAS IMPLANTED BY ANOTHER SURGEON. THE STEM FROM THE PRIMARY REVERSE SHOULDER WHICH I BELIEVE WAS DONE AND CAME LOOSE. THE CAUSE IS UNKNOWN AS TO WHY THE STEM CAME LOOSE. THE ORIGINAL BASEPLATE AND FOUR PERIPHERAL SCREWS REMAINED IN TACT AND WELL FIXED IN THE PATIENT. WHEN WE WENT IN FOR THE REVISION SHOULDER, A NEW 6X175 SMALL SHELL ALTIVATE REVERSE STEM WAS CEMENTED INTO THE PATIENT WITH THE USE OF A SZ. 8 CEMENT RESTRICTOR. A LARGER 40MM HEAD WAS ALSO USED TO FILL THE JOINT SPACE AND PROVIDE FURTHER STABILITY ALONG WITH A +4 SEMI-CONSTRAINED POLY.

  Patient problems: No Information

  MAUDE report 9286002 ↗
• InjuryDec 18, 2018Loose or Intermittent Connection

  THIRD REVISION SURGERY - DUE TO THE STEM BEING LOOSE.

  Patient problems: No Information

  MAUDE report 8175392 ↗
• InjuryJul 7, 2017Patient-Device Incompatibility

  REVISION SURGERY - DUE TO AN INFECTED TOTAL SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 6694579 ↗
• InjuryMay 12, 2017Failure To Adhere Or Bond

  REVISION SURGERY - DUE TO THE CEMENTED MODULAR REVERSE SHOULDER PROSTHESIS (RSP) HUMERAL COMPONENTS HAVING ASEPTICALLY LOOSENED AND WERE CAUSING PAIN. THE ORIGINAL COMPONENTS WERE REMOVED WITHOUT MUCH DIFFICULTY AND A CEMENTED 8MM MONOBLOCK STEM, +8MM SPACER AND A +4MM SEMI - CONSTRAINED LINER WERE THEN IMPLANTED TO THE SURGEONS SATISFACTION. ALL OF THE GLENOID COMPONENTS WERE WELL FIXED AND REMAINED.

  Patient problems: Pain

  MAUDE report 6563951 ↗
• InjuryDec 22, 2015Device Slipped

  SECOND REVISION SURGERY - DUE TO THE STEM LOOSENING.

  Patient problems: No Code Available

  MAUDE report 5319936 ↗
• InjurySep 23, 2015Device Slipped

  REVISION SURGERY - DUE TO THE PATIENT EXPERIENCING DISCOMFORT; THE SURGEON FELT THE STEM HAD COME LOOSE.

  Patient problems: Discomfort

  MAUDE report 5097353 ↗

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