MAUDE Adverse Event Report: OMNILIFE SCIENCE INC. APEX KNEE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIA

Model Number	KC-36034
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	03/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Range of motion is addressed in risk analysis fmea k-078 risk id-50 & 51 rpn=16.The instructions for use do include this possible adverse effect:" inadequate range of motion due to improper selection or positioning of components, boney impingement and periarticular calcification." 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 or Problem Description
A complaint was initiated for a patient who underwent a knee revision surgery on (b)(6) 2020.The original surgery date is (b)(6) 2019.The reason for revision is reported poor range of motion/stiff knee.During the revision, the apex ultra knee and retaining bolt were replaced with new components of the same size.

• Brand Name: APEX KNEE
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIA
• Manufacturer (Section D): OMNILIFE SCIENCE INC.; 480 paramount dr.; raynham, ma
• MDR Report Key: 9874746
• Report Number: 1226188-2020-00051
• Device Sequence Number: 16939797
• Product Code: JWH
• UDI-Device Identifier: 00841690101628
• UDI-Public: 00841690101628
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2021
• Device Model Number: KC-36034
• Device Catalogue Number: KC-36034
• Device Lot Number: 25737
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR