DJO SURGICAL 391-15-708Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888912119771), received between Jun 27, 2019 and Jun 21, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K091956); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 21, 2023Adverse 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 17175905 ↗
• InjuryOct 12, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - IRRIGATION & DRAINAGE PERFORMED DUE TO INFECTION AND SWAP OUT.

  Patient problems: Unspecified Infection

  MAUDE report 12618994 ↗
• InjuryOct 13, 2020Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO AN INFECTION, SURGEON DID AN IRRIGATION & DRAINAGE.

  Patient problems: Unspecified Infection

  MAUDE report 10671338 ↗
• InjuryJun 27, 2019Inadequacy of Device Shape and/or Size; Unstable; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - THE PATIENT'S KNEE WAS UNSTABLE; NEEDED TO INCREASE INSERT SIZE.

  Patient problems: No Information

  MAUDE report 8742782 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091956. One submission often covers many models, so check the product and lot details in each record.

• Z-2659-2017 · May 31, 2017 · Terminated
  3DKNEE(TM) SYSTEM e+, Tibial Insert, RIGHT Sz 8 / 11mm, REF 391-11-708, QTY 01 The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene
• Z-2658-2017 · May 31, 2017 · Terminated
  3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene
• Z-1213-2013 · Apr 1, 2013 · Terminated
  3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
• Z-2302-2012 · Aug 9, 2012 · Terminated
  3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is intended to more closely match the kinematics of the knee, allowin