MAUDE Adverse Event Report: BIOMET ORTHOPEDICS OXF TWIN-PEG CMNTD FEM SM PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/18/2014

Event Type  malfunction  

Event Description

It was reported that patient underwent an oxford partial knee arthroplasty on (b)(6) 2014.During the procedure, the femoral component was found to have "build up" from machining process on the back near the bottom.Another oxford femoral component was utilized to complete the procedure.

Manufacturer Narrative

The returned unit was evaluated and found to have polishing compound around one of the pegs.Remaining units manufactured on this lot of product have been implanted or inspected with no reported issues found.Therefore, this is considered an isolated incident.

• Brand Name: OXF TWIN-PEG CMNTD FEM SM PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET U.K. LTD.; waterton industrial estate; bridgend, south wales; warsaw, 441.65.66.55.221 CF31 3XA; UK CF31 3XA
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4552074
• MDR Text Key: 5525265
• Report Number: 0001825034-2015-00732
• 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: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 161468
• Device Lot Number: 104070
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2015
• Initial Date FDA Received: 02/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2014
• 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