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DJO SURGICAL 110-02-026Recalls & reported problems

Encore Medical, L.P. · PATELLA,METAL BACKED 26MM W/NS BEADS · Class 2 · Implant

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

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888912108256), received between Oct 1, 2015 and Sep 1, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Malposition of Device” (1 report).

1 other recall cover devices cleared under the same FDA submission (K932246); 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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Appropriate Device Problem Term/Code Not Available1
  • Malposition of Device1

Patient problems

  • Pain3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjurySep 1, 2020Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY - DUE TO PATELLA PAIN.

    Patient problems: Pain

    MAUDE report 10476882 ↗
  • InjuryJun 6, 2019Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY - DUE TO PAIN.

    Patient problems: Pain

    MAUDE report 8676971 ↗
  • InjuryOct 1, 2015Malposition of Device

    SECOND REVISION SURGERY - DUE TO INTERIOR KNEE PAIN; THE PATELLA WAS INSET TOO FAR. (B)(4).

    Patient problems: Pain

    MAUDE report 5117644 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K932246. One submission often covers many models, so check the product and lot details in each record.

  • Z-1255-2010 · Feb 22, 2010 · Terminated
    Foundation Knee System, Patella Trial, 26 mm, part number 802-01-019, Lot number 53944551

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

How reports and recalls are matched · Editorial policy · Report an error on this page