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U.S. Department of Health and Human Services

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

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BIOMET ORTHOPEDICS VANGUARD CR FEMORAL 65MM LEFT INTERLOK PROSTHESIS, KNEE   Back to Search Results
Model Number N/A
Device Problem Implant, removal of
Event Date 10/19/2010
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
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).

 
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. This report filed (b)(4), 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.

 
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.

 
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Brand NameVANGUARD CR FEMORAL 65MM LEFT INTERLOK
Type of DevicePROSTHESIS, 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 Key1942057
MDR Report Key1912914
Event Key1809912
Report Number1825034-2010-00634
Device Sequence Number1
Product CodeJWH
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 Received12/02/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Physician
Device EXPIRATION Date02/28/2019
Device MODEL NumberN/A
Device Catalogue Number183028
Device LOT Number285080
OTHER Device ID NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date11/30/2010
Event Location Hospital
Was The Report Sent To Manufacturer? No
Date Manufacturer Received11/05/2010
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/12/2009
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

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