MAUDE Adverse Event Report: BODYCAD LABORATORIES, INC BC REFLEX UNI; UNICOMPARTMENTAL KNEE

Model Number	018001
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient underwent a right knee partial arthroplasty.After 30 days, the patient reported pain a x-rays demonstrated tibial fracture.It was noted that the device had no defect and review of the device history record indicates that the device was manufactured to specifications.The event was not caused by wrong labeling or wrong instructions for use.Bodycad considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened and a follow-up medical device report will be filed accordingly.
Event or Problem Description
The patient underwent a right knee partial arthroplasty.The patient pain after 30 days post implantation due to fractured tibia bone.Clear fracture in the anterior part of the tibia.Fracture was not displaced.The doctor treated the patient conservatively with screws across the fracture line.

• Brand Name: BC REFLEX UNI
• Common Device Name: UNICOMPARTMENTAL KNEE
• Manufacturer (Section D): BODYCAD LABORATORIES, INC; 2035 rue du haut-bord; quebec, quebec G1N 4 R7; CA G1N 4 R7
• MDR Report Key: 11805189
• Report Number: 3012086398-2021-00002
• Device Sequence Number: 4395453
• Product Code: HSX
• UDI-Device Identifier: 00688346000061
• UDI-Public: 00688346000061
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: 196996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 05/10/2021

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: No Information
• Device Model Number: 018001
• Device Catalogue Number: 018-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 05/11/2021
• 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: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 104