MAUDE Adverse Event Report: OMNI LIFE SCIECE, INC. APEX KNEE SYSTEM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL

Model Number KC-2203R-HP

Device Problem Collapse (1099)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/22/2021

Event Type  Injury  

Manufacturer Narrative

The complainant made no indication of any omnilife science device malfunction or deficiency related to the identity, quality, durability, reliability, safety, effectiveness or device performance contributing to the adverse event.Review of the manufacturing documentation and sterilization documentation for the devices in question revealed no deviation from process or non-conformity of product that would have caused or contributed to the adverse event.

Event Description

A complaint was initiated for a patient who underwent a knee revision surgery on (b)(6) 2021.The original surgery date is (b)(6) 2021.The reason for revision is reported collapsed tibia.During the revision the insert, femur, base plate, and bolt were removed and replaced with new components.

• Brand Name: APEX KNEE SYSTEM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL
• Manufacturer (Section D): OMNI LIFE SCIECE, INC.; 480 paramount drive; raynham MA 02767
• Manufacturer (Section G): OMNI LIFE SCIECE, INC.; 480 paramount drive; raynham MA 02767
• Manufacturer Contact: jamie demedeiros ; 480 paramont dr.; raynham 02767 ; 7742261848
• MDR Report Key: 12579178
• MDR Text Key: 274824791
• Report Number: 1226188-2021-00119
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00841690130819
• UDI-Public: 00841690130819
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KC-2203R-HP
• Device Catalogue Number: KC-2203R-HP
• Device Lot Number: 38323
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR