DJO SURGICAL 391-09-608Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888912118897), received between Dec 19, 2018 and Sep 23, 2026 — classified as 10 injuries.

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

• InjurySep 23, 2026Unstable

  Patient problems: Joint Laxity

  MAUDE report 50862962 ↗
• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO WORN POLY.

  Patient problems: Joint Laxity

  MAUDE report 18744663 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - POLY WEAR.

  Patient problems: Joint Laxity

  MAUDE report 17083746 ↗
• InjuryJan 8, 2021Naturally Worn; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - TIBIAL INSERT HAD BECOME WORN OVER TIME AND POLY EXCHANGE WAS REQUIRED TO PREVENT FURTHER EROSION.

  Patient problems: Insufficient Information

  MAUDE report 11142704 ↗
• InjuryDec 30, 2019Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - THE PATIENT HAD AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9530613 ↗
• InjurySep 23, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - PATIENT FELL AND FRACTURED THE PATELLA. THERE WAS NO PLACE TO REATTACH A PATELLA SO SURGEON DID NOT REPLACE PATELLA. REPLACED INSERT DUE TO WEAR.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 9105718 ↗
• InjuryJun 21, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION IN KNEE. THE SURGEON PERFORMED A WASH OUT AND EXCHANGED OUT THE INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 8724642 ↗
• InjuryJun 21, 2019Naturally Worn; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY DUE TO FEMUR WORN THROUGH POST, LATERAL ASPECT OF TIBIAL INSERT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8722946 ↗
• InjuryApr 4, 2019Naturally Worn

  REVISION SURGERY - DUE TO A WORN POLY.

  Patient problems: No Code Available

  MAUDE report 8484284 ↗
• InjuryDec 19, 2018Loose or Intermittent Connection

  REVISION SURGERY - DUE TO A LOOSE SIZE 8 3D POROUS TIBIA AND SIZE 8 3D FEMUR.

  Patient problems: No Code Available

  MAUDE report 8182231 ↗

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