MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT LG SIZE 7 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problems Material Separation (1562); Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); No Code Available (3191)

Event Date 12/09/2014

Event Type  Injury  

Event Description

It was reported patient underwent a right partial knee arthroplasty on (b)(6) 2013.Subsequently, patient underwent a revision procedure on (b)(6) 2014 due to a disassociated tibial bearing.

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.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.Review of device history records show that lot released with no recorded anomaly or deviation.Product left conforming to print as there is no evidence that states otherwise.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, ¿dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity can also contribute to these conditions.".

Manufacturer Narrative

This follow-up report is being filed to relay the evaluation codes which were previously omitted in error when providing the results of the device evaluation.

Manufacturer Narrative

This follow-up report is being filed to correct information that was reported in error on a previous medwatch.

Event Description

It was reported patient underwent a right partial knee arthroplasty on (b)(6) 2013.Subsequently, patient underwent a revision procedure on (b)(6) 2014 due to a dislocated tibial bearing.The tibial bearing was removed and replaced.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

• Brand Name: OXF ANAT BRG RT LG SIZE 7 PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estate; brigend IN 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: 4382891
• MDR Text Key: 5123023
• Report Number: 0001825034-2015-00008
• 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: Consumer,consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 159586
• Device Lot Number: 2663980
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2012
• 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: 61 YR