DJO SURGICAL 392-09-608Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888912120197), received between Oct 2, 2015 and Jan 9, 2023 — classified as 8 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (3 reports).

5 other recalls cover devices cleared under the same FDA submission (K020114); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2023Naturally Worn; Naturally Worn

  REVISION SURGERY - DUE TO POLY WEAR.

  Patient problems: Joint Laxity

  MAUDE report 16127439 ↗
• InjuryDec 20, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO IRRIGATION & DEPRIVATION.

  Patient problems: No Code Available

  MAUDE report 9505469 ↗
• InjuryJun 18, 2019Naturally Worn; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO POLY WEAR.

  Patient problems: No Information

  MAUDE report 8708536 ↗
• InjuryMay 30, 2018Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO MEDIAL WEAR CAUSING INSTABILITY.

  Patient problems: Failure of Implant

  MAUDE report 7553860 ↗
• InjuryApr 4, 2018Loose or Intermittent Connection

  REPORTED INCIDENT - DUE TO RIGHT KNEE PAIN, LOOSE HARDWARE.

  Patient problems: Pain

  MAUDE report 7397361 ↗
• InjuryDec 28, 2017Loose or Intermittent Connection

  REVISION SURGERY - DUE TO THE PATIENT'S KNEE BEING A LITTLE LOOSE. THE SURGEON WANTED TO UPSIZE THE POLY.

  Patient problems: No Code Available

  MAUDE report 7150662 ↗
• InjuryJun 6, 2017Inadequacy of Device Shape and/or Size; Unstable

  REVISION SURGERY: AFTER A PRIMARY TOTAL KNEE ARTHROPLASTY (TKA) THE PATIENT DEVELOPED ARTHROFIBROSIS POSTOPERATIVELY; AFTER MANIPULATION SHE HAD ANOTHER LYSIS OF ADHESIONS. A POLY EXCHANGE WAS DONE TO CHANGE FROM A 11MM TO A 9MM TO HELP REGAIN MORE MOTION. THE PATIENT HAS GRADUALLY REGAINED MUCH OF HER LOST FEXION, BUT AS THIS HAPPENED HER KNEE BEGAN TO FEEL LESS STABLE AND HAD SOME PAIN WITH THIS INSTABILITY. A BONE SCAN SHOWED SOMETHING AT THE TIBIA THAT THEY THOUGHT MAY BE LOOSENING. HOWEVER IN SURGERY TODAY HER BASEPLATE WAS FOUND TO BE WELL FIXED AND THE ONLY OBVIOUS TIBIAL ISSUE WAS WEAR ON THE MEDIAL ASPECT OF POLY INSERT. AS SUCH, THEY DECIDED TO GO BACK UP TO AN 11MM TO BOTH GIVE HER A THICKER INSERT FOR LONGER WEAR AND HOPING THIS WOULD HELP MAKE HER KNEE FEEL STABLE AGAIN AND HOPEFULLY SOLVE THE ISSUES.

  Patient problems: Adhesion(s); Fibrosis; Pain

  MAUDE report 6616281 ↗
• InjuryOct 2, 2015Loose or Intermittent Connection; Device Dislodged or Dislocated

  REVISION SURGERY - DUE TO THE PATIENT PRESENTING WITH KNEE PAIN. THE SURGEON FELT THE INSERT MAY HAVE BEEN LOOSE AND THAT THE TIBIA HAD SUBSIDED; HE WANTED TO PUT IN A THICKER INSERT.

  Patient problems: Pain

  MAUDE report 5124301 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K020114. One submission often covers many models, so check the product and lot details in each record.

• Z-2244-2010 · Jun 28, 2010 · Terminated
  3DKnee Baseplates, Size 8, Left, Part # 333-01-108, Lot# A1000003.
• Z-1433-2010 · Mar 19, 2010 · Terminated
  3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM, Sterile, Right, size 4 x 11mm. Encore Medical, LP. Austin, TX 78758-5445. Intended to aid the surgion in relieving the patient of knee
• Z-1539-2008 · Feb 20, 2008 · Terminated
  3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured by Encore Medical, L.P., Austin, TX 78758. Used in surgery to determine the correct size of 3DKnee
• Z-0332-06 · Nov 3, 2005 · Terminated
  Size 8 right 3DKnee Non-porous Baseplates (Catalog #333-02-108) joint knee replacement.
• Z-1011-04 · May 10, 2004 · Terminated
  3DKnee System, Stemmed Tibia-Nonporous-3D, Size 6, Right, sterile. Manufactured by Encore Orthopeadics, 9800 Metric Blvd., Austin, Texas 78758