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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VNGD ANT STBLZD BRG 10X71 PROSTHESIS, KNEE

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BIOMET ORTHOPEDICS VNGD ANT STBLZD BRG 10X71 PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Bearings (734); Unstable (1667); Locking Mechanism (3083)
Patient Problem Pain (1994)
Event Date 03/30/2015
Event Type  Injury  
Event Description

It was reported patient underwent initial right knee arthroplasty procedure on an unknown date. Subsequently, patient was revised on (b)(6) 2015 due to pain and instability. The tibial bearing and locking bar were removed and replaced.

 
Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event. The following sections could not be completed with the limited information provided. Date of implant, lot code / expiration date, manufacture date. There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: "intraoperative or postoperative bone fracture and/or postoperative pain. ".

 
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Brand NameVNGD ANT STBLZD BRG 10X71
Type of DevicePROSTHESIS, 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 Key4715140
MDR Text Key16859996
Report Number0001825034-2015-01673
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberPK050222
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/30/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/21/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL NumberN/A
Device Catalogue Number189060
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/30/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 04/21/2015 Patient Sequence Number: 1
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