MAUDE Adverse Event Report: BODYCAD LABORATORIES, INC. BODYCAD UNICOMPARTMENTAL KNEE SYSTEM

Model Number 010003

Device Problem Migration (4003)

Patient Problem Toxicity (2333)

Event Date 07/18/2018

Event Type  Injury  

Manufacturer Narrative

Review of the device history record indicates that the device was manufactured to specification.The reason for femoral and tibial component loosening is unknown.

Event Description

Surgical intervention, i.E.Revision knee surgery, for loosening of unicompartmental femoral and tibial components.

• Brand Name: BODYCAD UNICOMPARTMENTAL KNEE SYSTEM
• Type of Device: UNICOMPARTMENTAL KNEE
• Manufacturer (Section D): BODYCAD LABORATORIES, INC.; 2035 rue du haut-bord; quebec, quebec G1N 4 R7; CA G1N 4R7
• Manufacturer (Section G): BODYCAD LABORATORIES, INC.; 2035 rue du haut-bord; quebec, quebec G1N 4 R7; CA G1N 4R7
• Manufacturer Contact: guy sévigny ; 2035 rue du haut-bord; quebec, quebec G1N 4-R7 ; CA G1N 4R7
• MDR Report Key: 7919999
• MDR Text Key: 122130946
• Report Number: 3012086398-2018-00001
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 010003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2017
• 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): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 109