MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT MD SIZE 6 PMA; PROTHESIS, KNEE

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528)

Patient Problem Fall (1848)

Event Date 11/18/2015

Event Type  Injury  

Event Description

It was reported that patient underwent left partial knee arthroplasty on (b)(6) 2013.Subsequently, patient was revised on (b)(6) 2015 due to a migrated tibial bearing after a patient fall.During the procedure, the original bearing was left in the patient as it was unable to be removed.The procedure was completed by implanting a new tibial bearing.There have been no reported complications or revision procedure to date.

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 10 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.".

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 that patient underwent left partial knee arthroplasty on (b)(6) 2013.Subsequently, patient was revised on (b)(6) 2015 due to a migrated tibial bearing after a patient fall.During the procedure, the original bearing was left in the patient as it was unable to be removed.The procedure was completed by implanting a new tibial bearing.Additional information received reported the patient was revised on november 18, 2015.The patient was converted to a total knee system.

Manufacturer Narrative

This follow-up report is being filed to correct and relay additional information, which was unknown at the time of the initial medwatch.The following sections could not be completed with the limited information provided.Remains implanted this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-02535 / 05108).

Event Description

It was reported that patient underwent left partial knee arthroplasty on (b)(6) 2013.Subsequently, patient was revised on (b)(6) 2015 due to a migrated tibial bearing after a patient fall.During the procedure, the original bearing was left in the patient as it was unable to be removed.The procedure was completed by implanting a new tibial bearing.Additional information received reported the patient was revised on (b)(6) 2015.The patient was converted to a total knee system.Additional information received reported the patient was revised on (b)(6) 2015 due to pain and discomfort.The original bearing remains in the patient.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-02535 / 05108).Product location unknown.

• Brand Name: OXF ANAT BRG LT MD SIZE 6 PMA
• Type of Device: PROTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; 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: 4838155
• MDR Text Key: 5942693
• Report Number: 0001825034-2015-02535
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 159550
• Device Lot Number: 394080
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2013
• 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): Disability
• Patient Age: 68 YR