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

Catalog Number 010-003

Device Problem Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/23/2019

Event Type  Injury  

Manufacturer Narrative

The patient underwent a right knee partial arthroplasty.After 6 weeks, the patient reported pain and the joint was unstable due to subsidence of the tibial component.It was noted that the device had no defect and that the cement interface was intact.The implant was revised to a primary cr knee.Explants were not made available to the manufacturer.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.The reason for implant subsidence is unknown.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.

Event Description

The patient underwent a right knee partial arthroplasty.The patient reported pain after 6 weeks.At diagnosis, subsidence of the tibial plateau was observed.The prosthesis was revised to a total knee (cr).

• Brand Name: BODYCAD UNICOMPARTMENTAL KNEE SYSTEM
• Type of Device: UNICOMPARTMENTAL KNEE
• Manufacturer (Section D): BODYCAD LABORATORIES INC.; 2035 rue du haut-bord; quebec, G1N4R 7; CA G1N4R7
• Manufacturer (Section G): BODYCAD LABORATORIES INC.; 2035 rue du haut bord; quebec, G1N4R 7; CA G1N4R7
• Manufacturer Contact: guy sevigny ; 2035 rue du haut bord; quebec, quebec G1N4R-7 ; CA G1N4R7
• MDR Report Key: 8682811
• MDR Text Key: 147461408
• Report Number: 3012086398-2019-00001
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 010-003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2019
• 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: 51 YR
• Patient Weight: 98