MAUDE Adverse Event Report: BIOMET ORTHOPEDICS OXF ANAT BRG RT MD SIZE 6 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Type  Injury  

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 12 states, "inadequate range of motion due to improper selection or positioning of components." number 20 states, "persistent pain.".

Event Description

It was reported that the clinical patient had an initial right oxford knee procedure on (b)(6), 2007.The patient has reported pain and difficulty bending the knee on (b)(6), 2011.No revision procedure has been reported.

• Brand Name: OXF ANAT BRG RT MD SIZE 6 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: 5090594
• MDR Text Key: 26268716
• Report Number: 0001825034-2015-04022
• 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: study
• Reporter Occupation: Physician
• Report Date: 09/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/29/2012
• Device Model Number: N/A
• Device Catalogue Number: 159578
• Device Lot Number: 1289243
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2007
• 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): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 141