MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN KNEE; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 04/07/2014

Event Type  Injury  

Event Description

It was reported patient underwent a total knee arthroplasty on an unknown date.It has been suggested that the patient will need to undergo a revision procedure due to an unknown reason.There has been no reported revision procedure to date.

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the limited information provided.Date of event - unknown, expiration date - unknown, date implanted - unknown, date explanted - unknown, pma/510(k) number - unknown, manufacture date ¿ unknown.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

It was reported patient underwent a total knee arthroplasty on an unknown date.Subsequently, patient was revised on (b)(6) 2014 due to an unknown reason.The tibial bearing and locking bar were removed and replaced.

• Brand Name: UNKNOWN KNEE
• 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: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3782188
• MDR Text Key: 17986938
• Report Number: 0001825034-2014-03443
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNK KNEE
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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