APEX CR Knee KC-1101LRecalls & reported problems

Omni Life Science, Inc. · CR Femoral Cemented, Size 1 Left · Class 2 · Implant

All models of APEX CR Knee (28)

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

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841690100805), received between Feb 17, 2017 and Nov 5, 2024 — classified as 2 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 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Loosening of Implant Not Related to Bone-Ingrowth1
Unstable1

Patient problems

Joint Laxity1
Pain1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryNov 5, 2024Loosening 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 10/21/2024. THE ORIGINAL SURGERY IS DATED (B)(6) 2016. THE REASON FOR REVISION IS REPORTED LOOSENING AFTER PATIENT FALL. DURING THE REVISION THE FEMUR, INSERT AND BOLT WE REMOVED AND REPLACED WITH A NEW IMPLANTS.
Patient problems: Joint Laxity
MAUDE report 20608561 ↗
InjuryFeb 17, 2017Unstable
THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A SECOND KNEE REVISION SURGERY ON (B)(6) 2017. THE FIRST REVISION OCCURRED ON (B)(6) 2013 AND THE ORIGINAL SURGERY IS DATED (B)(6) 2013. THE REVISION SURGERY OCCURRED BECAUSE OF INSTABILITY IN THE KNEE AND PATIENT PAIN. DURING THIS REVISION, THE ORIGINAL SIZE 2 TIBIAL BASEPLATE, AND SIZE 1 FEMORAL COMPONENT WERE REMOVED ALONG WITH THE SIZE 1 X 20 MM INSERT AND RETAINING BOLT FROM THE FIRST REVISION SURGERY. THE COMPONENTS WERE REPLACED WITH A NEW SIZE 2 TIBIAL BASEPLATE, A SIZE 1+ FEMUR, A SIZE 1 X 10 MM TIBIAL INSERT AND RETAINING BOLT. IN ADDITION, TWO MODULAR STEMS, FOUR FEMORAL AUGMENTS AND BOLTS, AND TWO TIBIAL AUGMENTS AND BOLTS WERE IMPLANTED.
Patient problems: Pain
MAUDE report 6340436 ↗

Device details

UDI-DI	`00841690100805`
Brand	APEX CR Knee
Model	KC-1101L
Company	Omni Life Science, Inc.
Product code	JWH · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 13, 2021

Device type (GMDN): Uncoated knee femur prosthesis, metallic

An implantable device designed to replace the femoral condyles (femoral component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo), titanium (Ti)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with tibial and, if required, patellar prosthetic components of the knee joint and its implantation is intended to be performed with bone cement.

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

ATTUNE 1506-00-005
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
589 reports
ATTUNE 1506-00-004
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
580 reports
JOURNEY 74012812
Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
502 reports
JOURNEY 74011856
Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
438 reports
PERSONA™ 42-5099-094-00
Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
406 reports
JOURNEY 74011857
Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
388 reports
ATTUNE 1506-00-007
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
288 reports
ATTUNE 1506-00-003
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
271 reports

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

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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