MAUDE Adverse Event Report: BIOMET ORTHOPEDICS OXF ANAT BRG RT MD SIZE 4 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Scar Tissue (2060)

Event Date 09/11/2015

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.

Event Description

It was reported that the patient underwent a right total knee arthroplasty on (b)(6) 2014.Subsequently, a revision procedure was performed on (b)(6) 2015 due to excessive scar tissue causing catching in the medial compartment.During the procedure, scar tissue was removed and the polyethylene tibial bearing was removed and replaced.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.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.Due to wear and major pitting of the polyethylene component dimensional analysis was unable to be adequately performed.Evaluation of the component determined the worn posteromedial corner was caused by osteophytes which wore the corner causing debris to move into the articulating surface.It is unknown if the reported catching of the medial compartment due to excessive scar tissue is related.Shorter part life of 10 months and 15 days suggests the possibility of unsuitable intraoperative bone preparation and/or patient condition lead to the excessive wear of the polyethylene.Without more information, no root cause could be determined with a sufficient likelihood.

• Brand Name: OXF ANAT BRG RT MD SIZE 4 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: 5112018
• MDR Text Key: 27053527
• Report Number: 0001825034-2015-04116
• 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: Followup,Followup
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 159576
• Device Lot Number: 151850
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/26/2015; 11/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2014
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 89