MAUDE Adverse Event Report: BIOMET ORTHOPEDICSVANGUARD CR FEMORAL 65MM LEFT INTERLOKPROSTHESIS, KNEE

Model Number N/A

Device Problem Implant, removal of

Event Date 10/19/2010

Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization

Event Description

It was reported that patient underwent total knee arthroplasty on (b)(6), 2009. Subsequently, a revision procedure was performed on (b)(6), 2010 due to recurrent effusion and metal allergy. The femoral component, tibial plate and tibial bearing were all removed and replaced.

Manufacturer Narrative

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: possible adverse effect #1 - material sensitivity reactions. Implantation of foreign material in tissues can result in histological reactions involving various sizes of macrophages and fibroblasts. The clinical significance of this effect is uncertain, as similar changes may occur as a precursor to or during the healing process. The user facility was notified of the event on november 30, 2010. To date, a response has not been received from the user facility. In the event that the user facility submits a medwatch report, biomet will forward a copy to the fda. Evaluation in process but not yet complete. Upon completion of evaluation, a follow up report will be sent to the fda. (b)(4).

Manufacturer Narrative

Review of device history records show that lot released with no recorded anomaly or deviation. This report filed (b)(4), 2011.

Manufacturer Narrative

Evaluation was not necessary based on the event being reported. Information relayed in the attached user facility report indicates the patient's knee functioned well, but she had recurrent effusion and allergy testing showed high positive correlation with nickel. This report filed (b)(6), 2011.

Event Description

It was reported that patient underwent total knee arthroplasty on (b)(6), 2009. Subsequently, a revision procedure was performed on (b)(6), 2010 due to recurrent effusion and metal allergy. The femoral component, tibial plate and tibial bearing were all removed and replaced.

Manufacturer Narrative

Evaluation of the returned component found residual bone and bone cement. The articulating surface has some condyle wear marks. There are no major wear areas, scratches or gouges. This report filed (b)(6), 2011.

Event Description

It was reported that patient underwent total knee arthroplasty on (b)(6), 2009. Subsequently, a revision procedure was performed on (b)(6), 2010 due to recurrent effusion and metal allergy. The femoral component, tibial plate and tibial bearing were all removed and replaced.

Event Description

It was reported that patient underwent total knee arthroplasty on (b)(6), 2009. Subsequently, a revision procedure was performed on (b)(6), 2010 due to recurrent effusion and metal allergy. The femoral component, tibial plate and tibial bearing were all removed and replaced.

• Brand Name: VANGUARD CR FEMORAL 65MM LEFT INTERLOK
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section F): BIOMET ORTHOPEDICS; 56 east bell drive; p.o. box 587; warsaw IN 46581 0587
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 east bell drive; p.o. box 587; warsaw IN 46581 0587
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 east bell drive; p.o. box 587; warsaw IN 46581 0587
• Manufacturer Contact: miranda parcels ; 56 east bell drive; p.o. box 587; warsaw , IN 46581-0587; (574) 267 -6639 ext 3756
• Device Event Key: 1942057
• MDR Report Key: 1912914
• Event Key: 1809912
• Report Number: 1825034-2010-00634
• Device Sequence Number: 1
• Product Code: JWH
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/05/2010

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 12/02/2010
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Physician
• Device EXPIRATION Date: 02/28/2019
• Device MODEL Number: N/A
• Device Catalogue Number: 183028
• Device LOT Number: 285080
• OTHER Device ID Number: N/A
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Is The Reporter A Health Professional?: Yes
• Distributor Facility Aware Date: 11/30/2010
• Event Location: Hospital
• Was The Report Sent To Manufacturer?: No
• Date Manufacturer Received: 11/05/2010
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 02/12/2009
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Is the Device an Implant?: No

Is this an Explanted Device?

• Type of Device Usage: Initial