MAUDE Adverse Event Report: BIOMET ORTHOPEDICS OXF ANAT BRG RT LG SIZE 3 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Damage to Ligament(s) (1952)

Event Date 12/18/2014

Event Type  Injury  

Event Description

It was reported that the patient underwent a right partial knee arthroplasty on (b)(6) 2014.Subsequently, the patient underwent a revision procedure on (b)(6) 2014 due to a ligament tear.All components were removed and a total knee system was implanted.

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 related to the event.

Event Description

It was reported that patient underwent a right partial knee arthroplasty on (b)(6) 2014.Subsequently, the patient underwent a revision procedure on (b)(6) 2014 due to a ligament tear.While putting in a fence post, patient tripped over one of the holes in the ground and fell most likely causing the ligament tear.All components were removed and a total knee system was implanted.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.

• Brand Name: OXF ANAT BRG RT LG SIZE 3 PMA
• 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: 4394027
• MDR Text Key: 5121086
• Report Number: 0001825034-2015-00080
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2016

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: 01/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 159582
• Device Lot Number: 2297371
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/23/2015
• Initial Date FDA Received: 01/07/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/10/2015; 03/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2011
• 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: 68 YR