MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VANGUARD M UNI BEARING A6 RM/LL; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Laceration(s) (1946); Injury (2348)

Event Date 02/18/2014

Event Type  Injury  

Event Description

It was reported that patient enrolled in a clinical study underwent right partial knee arthroplasty on (b)(6) 2012 and left partial knee arthroplasty on (b)(6) 2012.During post-operative monitoring and testing, patient experienced left knee popliteus snapping and a partial tear.Subsequently, patient underwent arthroscopy with debridement and popliteal tendon release of the left knee on (b)(6) 2014.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 14 states, "patellar tendon rupture and ligamentous laxity.".

• Brand Name: VANGUARD M UNI BEARING A6 RM/LL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4796056
• MDR Text Key: 20723424
• Report Number: 0001825034-2015-02221
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK021621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2015

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
• Device Operator: Physician
• Device Expiration Date: 02/28/2015
• Device Model Number: N/A
• Device Catalogue Number: US154745
• Device Lot Number: 386560
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2015
• Initial Date FDA Received: 05/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 65