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DJO SURGICAL 233-02-106Recalls & reported problems

Encore Medical, L.P. · FEMUR, NONPOROUS, 3D, SIZE6, RT · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888912111232), received between Aug 24, 2016 and Aug 15, 2018 — classified as 4 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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

Device problems

  • Loose or Intermittent Connection2
  • Unstable2
  • Insufficient Device Problem Information1
  • Naturally Worn1

Patient problems

  • No Code Available2
  • Failure of Implant1
  • Pain1
  • Unspecified Infection1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 15, 2018Loose or Intermittent Connection; Unstable

    REVISION SURGERY - DUE TO PAIN AND INSTABILITY JOINT. THE INITIAL SURGERY THE IMPLANTS WERE OVERSIZE AND LOOSE. THE SIZE 6 FEMUR AND 4 TIBIA WERE TAKEN OUT AND REVISED WITH A SIZE 4.

    Patient problems: Pain

    MAUDE report 7786890 ↗
  • InjuryAug 3, 2018Loose or Intermittent Connection; Naturally Worn

    REVISION SURGERY - DUE TO THE PATIENT BEING LOOSE. THE SURGEON FOUND THAT THE FEMUS WAS LOOSE AND THE POLY WAS WORN OUT. THE ORIGINAL IMPLANTS WERE REMOVED AND REPLACED.

    Patient problems: Failure of Implant; No Code Available

    MAUDE report 7748759 ↗
  • InjuryJan 26, 2018Unstable

    REVISION SURGERY - DUE TO THE PATIENT HAVING INSTABILITY.

    Patient problems: No Code Available

    MAUDE report 7222731 ↗
  • InjuryAug 24, 2016Insufficient Device Problem Information

    REVISION SURGERY - DUE TO THE PATIENT'S KNEE HAVING BECOME INFECTED SEVERAL YEARS FOLLOWING A TOTAL KNEE ARTHROPLASTY (TKA). THE SURGEON REMOVED ALL OF THE COMPONENTS AND CEMENTED IN AN ARTICULATING BEARING SPACER WITH ANTI-BIOTIC CEMENT.

    Patient problems: Unspecified Infection

    MAUDE report 5901511 ↗

Other PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices →

Sources and updates

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