MAUDE Adverse Event Report: ORTHO DEVELOPMENT BKS UNI; TOTAL KNEE ARTHROPLASTY PROSTHESIS

Model Number	762-2100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	07/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient who had unicompartmental knee arthroplasty on (b)(6) 2022 had an asthma attack two weeks later and subsequently complained of knee pain.An new x-ray showed tibial fractures that were not present at intra-operative and post operative checks.A second surgery was performed on (b)(6) 2022 to put in an orif plate with bone graft leaving the unicompartmental knee components in place.

• Brand Name: BKS UNI
• Common Device Name: TOTAL KNEE ARTHROPLASTY PROSTHESIS
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer (Section G): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer Contact: drew weaver ; 12187 s. business park drive; draper, UT 84020 ; 8015539991
• MDR Report Key: 15165543
• Report Number: 1722511-2022-00008
• Device Sequence Number: 4622999
• Product Code: HSX
• UDI-Device Identifier: 00822409109319
• UDI-Public: (01)00822409109319(17)270117(10)A263870
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K211471
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2022

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 Model Number: 762-2100
• Device Lot Number: A263870
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown