MAUDE Adverse Event Report: BODYCAD BODYCAD UNICOMPARTMENTAL KNEE SYSTEM; UNICOMPARTMENTAL KNEE,

Model Number 010003

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 03/18/2021

Event Type  Injury  

Manufacturer Narrative

Because of electronic reporting issues in esg test, this report is sent late.All technical support is now in place to avoid this kind of delay later.

Event Description

Patient had no associated trauma or fall.Patient presented to dr with pain.X-ray shows a broken tibial tray.Retrieval picture show a broken tibial baseplate.

Event Description

Following a pain complaint by patient an x-ray shows the damage to the tibial base plate.Surgical intervention, revision knee surgery, for breacking of tibial baseplate was performed.

Manufacturer Narrative

The returned tibial base plate was examined visually.The purpose of this investigation was to determine the cause for the fracture of the tibial base plate.The base plate was fractured into two pieces.Examination of the fracture surface revealed that fatigue was the fracture mechanism due to the presence of fatigue striations.Examination also revealed lack of cement adhesion to the posterior aspect of the plateau which could potentially lead to loosening.The cause of the tibial base plate fracture was likely due to fatigue loading in excess of the strength of the tray not properly supported by the bone / cement interface.

• Brand Name: BODYCAD UNICOMPARTMENTAL KNEE SYSTEM
• Type of Device: UNICOMPARTMENTAL KNEE,
• Manufacturer (Section D): BODYCAD; 2035 rue du haut-bord,; quebec, quebec G1N 4 R7; CA G1N 4R7
• MDR Report Key: 11664928
• MDR Text Key: 245370251
• Report Number: 3012086398-2021-00001
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K163700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 010003
• Device Catalogue Number: 010003
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/13/2021
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 100