MAUDE Adverse Event Report: BIOMET UK LTD. AGC ANATOM INTRLK FEM PROS R 70; PROSTHESIS, KNEE

Model Number N/A

Device Problem Delamination (2904)

Patient Problem No Code Available (3191)

Event Date 11/13/2015

Event Type  Injury  

Manufacturer Narrative

This follow-up report is being filed to 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: implant date - unknown.Examination of returned device found no evidence of product non-conformance.During the evaluation, the tibial and femoral component showed evidence of wear and scratching.Root cause of the event was most likely attributed to third party debris; however, a conclusive root cause could not be determined.There are warnings in the package insert that state that this type of event can occur: under adverse reactions, number 4 states, "particulate wear debris and discoloration from metallic or polyethylene components of joint implants may be present in adjacent tissue or fluid." under late postoperative complications, "excessive wear due to malalignment, migration, loosening or excessive loading." under warnings and precautions, number 2 states, "malalignment of the components can place inordinate forces on the components which may cause excessive wear." number 5 states, "inadequate preclosure cleaning (removal of surgical debris) can lead to excessive wear." number 7 states, "malalignment or soft tissue imbalance can place inordinate forces on the components, which may cause excessive wear to the patellar or tibial bearing articulating surfaces." this report is number 2 of 2 mdrs filed for the same patient (reference 3002806535-2015-04136 & 3002806535-2016-00023).

Event Description

It was reported that patient underwent a total knee arthroplasty on an unknown date.Subsequently, a revision procedure was performed on (b)(6) 2015 due to delamination of the polyethylene tibial bearing.

• Brand Name: AGC ANATOM INTRLK FEM PROS R 70
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: daniel tilbury ; waterton industrial estates; bridgend CF31 -3XA ; UK CF31 3XA ; 0441656655
• MDR Report Key: 5364312
• MDR Text Key: 35816803
• Report Number: 3002806535-2016-00023
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK833921
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 152836
• Device Lot Number: 1738739
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2009
• 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