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DJO SURGICAL 385-09-502Recalls & reported problems

Encore Medical, L.P. · INSERT, STD., PRIMARY, SIZE2 9MM CM · Class 2 · Implant

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

Adverse event reports
6
Deaths reported
0
Injuries reported
6
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888912117715), received between Sep 15, 2015 and Feb 28, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 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

  • Naturally Worn3
  • Unstable2
  • Adverse Event Without Identified Device or Use Problem1
  • Appropriate Device Problem Term/Code Not Available1
  • Loosening of Implant Not Related to Bone-Ingrowth1

Patient problems

  • Insufficient Information2
  • Implant Pain1
  • Joint Laxity1
  • No Code Available1
  • Pain1
  • Unspecified Infection1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 28, 2023Unstable; Unstable

    REVISION SURGERY - DUE TO POLY HAD WARN AND WAS CAUSING PAIN AND INSTABILITY.

    Patient problems: Implant Pain; Joint Laxity

    MAUDE report 16457387 ↗
  • InjuryDec 23, 2021Unstable; Naturally Worn

    REVISION SURGERY - PATIENT PRESENTED AT SURGEON OFFICE WITH KNEE INSTABILITY. UPON X-RAY REVIEW, IT WAS DETERMINED THAT THE POLY HAD WORN OUT AND NEEDED TO BE REPLACED. SURGEON ELECTED TO SWAP POLY FROM STANDARD FOUNDATION INSERT TO A ULTRA CONGRUENT OPTION AS THE PCL WAS RUPTURED.

    Patient problems: Insufficient Information

    MAUDE report 13079043 ↗
  • InjurySep 17, 2021Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth

    REVISION SURGERY - PATIENT PRESENTED EXTREME LAXITY, INSERTED A THICKER POLY.

    Patient problems: Insufficient Information

    MAUDE report 12492049 ↗
  • InjuryJun 19, 2020Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY - PATIENT HAD DEVELOPED AN INFECTION. SURGEON REMOVED THE POLY, DID A COMPLETE WASH OUT AND THEN REPLACED THE POLY.

    Patient problems: Unspecified Infection

    MAUDE report 10173745 ↗
  • InjuryAug 10, 2018Naturally Worn

    REVISION SURGERY - DUE TO THE PATIENT BEING PRESENTED WITH PAIN DUE TO POLY WEAR. THE SURGEON REPLACED THE POLY WITH THE SAME SIZE AS THE ONE REMOVED.

    Patient problems: Pain

    MAUDE report 7773883 ↗
  • InjurySep 15, 2015Naturally Worn

    REVISION SURGERY - DUE TO THE PATIENT'S KNEE HAVING SIGNS OF POLY WEAR; THE SURGEON REVISED THE POLY.

    Patient problems: No Code Available

    MAUDE report 5078337 ↗

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices →

Sources and updates

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