DJO SURGICAL 385-09-508Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00888912117760), received between Apr 22, 2016 and Apr 2, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Unstable” (2 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2026Unstable; Adverse Event Without Identified Device or Use Problem

  OVER THE YEARS THE PATIENT BECAME UNSTABLE, SO DR DECIDED TO DO A POLY SWAP TO THICKER POLY.

  Patient problems: Joint Laxity

  MAUDE report 24772472 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO WEAR

  Patient problems: Joint Laxity

  MAUDE report 23528625 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO POLY WEAR.

  Patient problems: Joint Laxity

  MAUDE report 19491275 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO POLY WEAR.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 19140539 ↗
• InjuryApr 21, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO PATIENT NOTICED SWELLING IN KNEE. PRIMARY SURGERY WAS DONE IN 2008, NO KNOWN ISSUES UNTIL NOW.

  Patient problems: Inflammation

  MAUDE report 11704181 ↗
• InjuryJul 11, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - PATIENT PRESENTED POST OP INFECTION THAT HAD SPREAD TO SURGICAL SIGHT. SURGEON PERFORMED IRRIGATION & DRAINAGE SWAPPING OUT THE POLY DURING CLEAN OUT.

  Patient problems: Unspecified Infection

  MAUDE report 8782995 ↗
• InjuryJul 5, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO THE PATIENT HAVING POST OPERATIVE NON RELATED INJURY TO SOFT TISSUE AND LIGAMENTS. TO REPAIR THIS ISSUE THE SURGEON REPLACED THE INSERT DURING THE PROCEDURE.

  Patient problems: Tissue Damage

  MAUDE report 8765488 ↗
• InjuryApr 11, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO POLY EXCHANGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8504812 ↗
• InjuryFeb 8, 2019Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO AN INFECTION, THE SURGEON REMOVED AND REPLACED THE INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 8322073 ↗
• InjuryFeb 7, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO THE PATIENT BEING PRESENTED WITH PAIN. THE SURGEON FELT IT WAS FROM POLY WEAR AND UNDER SIZED THE POLY (LEFT KNEE).

  Patient problems: Pain

  MAUDE report 8317552 ↗
• InjuryJan 2, 2019Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO THE PATIENT PRESENTING MULTIPLE TIMES TO THE DOCTOR COMPLAINING OF PAIN. DOCTOR CONSIDERED INSTABILITY. OPERATIVELY THE SURGEON FOUND NOTHING OF CONCERN; REPLACED THE POLY SINCE IT HAD BEEN DISRUPTED. THE DOCTOR NOW DOUBTS IF THE PATIENT HAD PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8210014 ↗
• InjuryAug 23, 2017Naturally Worn

  REVISION SURGERY: DUE TO THE PATIENT HAVING THE IMPLANT IN FOR OVER 10 YEARS AND THE POLY WEARING OUT.

  Patient problems: No Code Available

  MAUDE report 6815395 ↗
• InjuryMay 5, 2017Unstable

  REVISION SURGERY - THE PATIENT PRESENTED AT SURGEONS OFFICE WITH COMPLAINT OF INSTABILITY IN HIS KNEE. THE SURGEON DECIDED TO DO A POLY SWAP FROM A STANDARD CRUCIATE RETAINING (CR) TO AN ULTRA CONGRUENT INSERT.

  Patient problems: No Code Available

  MAUDE report 6549666 ↗
• InjuryFeb 2, 2017Loose or Intermittent Connection

  REVISION SURGERY - DUE TO THE PATIENT FALLING, IT CAUSED LOOSENING OF THE TIBIAL INSERT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6298058 ↗
• InjuryJan 13, 2017Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - THE SURGEON THOUGHT THERE WAS AN INFECTION; SO WENT IN TO DO AN IRRIGATION AND DRAINAGE AND SWAPPED THE POLY.

  Patient problems: Unspecified Infection

  MAUDE report 6251444 ↗
• InjuryApr 22, 2016Device Slipped

  REVISION SURGERY - DUE TO THE PATIENT HAVING PAIN AND LOOSENING.

  Patient problems: Pain

  MAUDE report 5599281 ↗