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APEX CR Knee KC-1102LRecalls & reported problems

Omni Life Science, Inc. · CR Femoral Cemented, Size 2 Left · Class 2 · Implant

All models of APEX CR Knee (28)

Data updated Oct 16, 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 00841690100829), received between Mar 10, 2017 and Oct 4, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

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 16, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Loosening of Implant Not Related to Bone-Ingrowth1
  • Unstable1

Patient problems

  • Failure of Implant1
  • Joint Laxity1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • InjuryOct 4, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

    A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2022. THE ORIGINAL SURGERY IS DATED 06/17/2019. THE REASON FOR REVISION IS REPORTED LOOSENING. DURING THE REVISION THE IMPLANTS, WAS REMOVED AND REPLACED WITH A NEW REVISION IMPLANTS.

    Patient problems: Joint Laxity

    MAUDE report 15538865 ↗
  • InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem

    A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2021. THE ORIGINAL SURGERY DATE IS (B)(6) 2013. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL FEMUR, TIBIAL TRAY, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH REVISION IMPLANTS.

    Patient problems: Failure of Implant

    MAUDE report 13257621 ↗
  • InjuryMar 10, 2017Unstable

    THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2011. THE REVISION SURGERY OCCURRED BECAUSE OF JOINT INSTABILITY. DURING THE REVISION, THE ORIGINAL SIZE 2 FEMORAL COMPONENT, SIZE 2 TIBIAL BASEPLATE, 29 MM X 8 MM PATELLA, SIZE 2 X 12 MM INSERT AND RETAINING BOLT WERE REVISED TO NEW NON-OMNI COMPONENTS.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6395103 ↗

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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