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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS OXFORD KEEL BLD STK HUB; CUTTER, WIRE

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BIOMET ORTHOPEDICS OXFORD KEEL BLD STK HUB; CUTTER, WIRE Back to Search Results
Model Number N/A
Device Problem Expiration Date Error (2528)
Patient Problem No Information (3190)
Event Date 02/05/2014
Event Type  Injury  
Event Description
It was reported patient underwent a partial knee arthroplasty on (b)(6) 2014.During the procedure, an expired blade was utilized.
 
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.
 
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Brand Name
OXFORD KEEL BLD STK HUB
Type of Device
CUTTER, WIRE
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
amanda zajicek
56 e. bell drive
warsaw, IN 46582
5743726782
MDR Report Key3692067
MDR Text Key17612165
Report Number0001825034-2014-01963
Device Sequence Number1
Product Code HXZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/21/2014
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 Date10/31/2012
Device Model NumberN/A
Device Catalogue Number506109
Device Lot Number97R240
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/21/2014
Initial Date FDA Received03/21/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/15/2007
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 Sequence Number1
Patient Outcome(s) Other;
Patient Age62 YR
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