MAUDE Adverse Event Report: BIOMET UK LTD OXF ANAT BRG RT MD SIZE 5 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Incorrect Device Or Component Shipped (2962)

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

Event Date 11/26/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent a partial knee arthroplasty on (b)(6) 2014.During the procedure, it was found that the implant box and inside packaging of the bearing both stated that it was a 5mm bearing.The product inside was a 4mm bearing.Another bearing was available to complete the procedure without significant delay.There was no injury to patient as a result.

Manufacturer Narrative

Examination of returned device found evidence of product non-conformance.The issue involved a mix of one unit from this lot and one unit from another lot due to inadequate line clearance during the manufacturing process.The unit from the other lot has been contained as it was not further distributed.Corrective actions have been initiated to address the reported issue.

• Brand Name: OXF ANAT BRG RT MD SIZE 5 PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD; bridgend; south wales CF31 3XA; UK CF31 3XA
• 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: 4620814
• MDR Text Key: 5576232
• Report Number: 0001825034-2015-01078
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 159577
• Device Lot Number: 459620
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2014
• 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