DJO SURGICAL 510-08-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888912024853), received between Sep 4, 2015 and Sep 15, 2025 — classified as 18 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 reports).

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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2025Mechanical Problem; Mechanical Problem

  COMPLAINT - THE 36 N POLY INSERT WOULD NOT IMPACT FLUSH ON THE 8MM SPACER USED SO ANOTHER POLY HAD TO BE OPENED. THE FIRST 8MM SPACER OPENED WOULD NOT SIT FLUSH ON THE STEM AND THE SET SCREW WOULD NOT THREAD DOWN INTO THE STEM, THERE WAS A 30 MINUTE DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23059675 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21862733 ↗
• InjuryJun 8, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO LOOSENING AND INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 19495035 ↗
• InjuryApr 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 19102520 ↗
• InjuryJul 18, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - PATIENT HAD PRIOR SURGERY FOR 4 PART PROXIMAL HUMERUS FIX. PATIENT DISLOCATED POST OPERATION. SURGEON DECIDED THAT A THICKER SPACER WAS NECESSARY. A CUSTOM 18 MM SPACER WAS MANUFACTURED ONKOS. SPACER WAS TRIALED AND IMPLANTED IN A REVISION SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 15048429 ↗
• InjuryJan 4, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 13161199 ↗
• InjuryAug 17, 2021Failure to Align; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO MISALIGNMENT.

  Patient problems: Insufficient Information

  MAUDE report 12333027 ↗
• InjuryDec 8, 2020Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO POLY DISASSOCIATION FROM STEM / 8MM SPACER.

  Patient problems: Failure of Implant

  MAUDE report 10968000 ↗
• InjuryNov 4, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - GLENOID COMPONENT LOOSE, POSSIBLE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10784316 ↗
• InjurySep 5, 2018Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - REVISED TO RULE OUT INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7848207 ↗
• InjuryMay 1, 2018Insufficient Device Problem Information

  REVISION SURGERY - DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7476418 ↗
• InjuryMar 16, 2018Device Dislodged or Dislocated

  REVISION SURGERY - DUE TO A DISLOCATION. THE PATIENT ORIGINALLY HAD A LONG SPIRAL FRACTURE OF THE HUMERUS. THE SURGEON CEMENTED A 175 ALTIVATE STEM INTO PLACE AND PROCEEDED TO DO A REVERSE TOTAL SHOULDER ARTHROPLASTY. THE PATIENT IS ON A WALKER AND SHE WAS HAVING ISSUES WITH HER SHOULDER DISLOCATING. AFTER, BRINGING HER BACK INTO SURGERY AND EXHAUSTING ALL OF OUR POLY THICKNESSES, IT WAS DETERMINED THAT THE BETTER COURSE OF ACTION WAS TO CONVERT HER SHOULDER TO A HEMI AS OPPOSED TO PULLING A VERY WELL FIXED, CEMENTED LONG STEM OUT ONLY TO CEMENT ANOTHER MORE PROXIMALLY.

  Patient problems: No Code Available

  MAUDE report 7346200 ↗
• InjuryMar 13, 2018Insufficient Device Problem Information

  SECOND REVISION SURGERY - DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7334265 ↗
• InjuryFeb 20, 2018Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO THE PATIENT EXPERIENCING PAIN. NOTHING WAS LOOSE WHEN PATIENT WAS REVISED.

  Patient problems: Pain

  MAUDE report 7283754 ↗
• InjuryJan 22, 2018Device Dislodged or Dislocated

  REVISION SURGERY - DUE TO THE PATIENT DISLOCATING.

  Patient problems: Joint Dislocation

  MAUDE report 7209845 ↗
• InjuryApr 5, 2016Device Dislodged or Dislocated

  REVISION SURGERY: DUE TO THE PATIENT'S REVERSE SHOULDER IMPLANT DISLOCATING; THE SURGEON CHANGED THE SIZE OF THE GLENOSPHERE AND POLYETHYLENE LINER. THERE WAS NOTHING WRONG WITH THE IMPLANTS THAT WERE EXPLANTED.

  Patient problems: No Code Available

  MAUDE report 5547704 ↗
• InjurySep 16, 2015Insufficient Device Problem Information

  THIRD REVISION SURGERY - DUE TO THE PATIENT DEVELOPING AN INFECTION AND REQUIRING A COMPONENT EXCHANGE.

  Patient problems: Unspecified Infection

  MAUDE report 5081445 ↗
• InjurySep 4, 2015Device Dislodged or Dislocated

  REVISION SURGERY - DUE TO CHRONIC DISLOCATION OF THE PATIENT'S JOINT.

  Patient problems: No Code Available

  MAUDE report 5058378 ↗