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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD OXF ANAT BRG LT LG SIZE 5 PMA; PROSTHESIS, KNEE

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BIOMET UK LTD OXF ANAT BRG LT LG SIZE 5 PMA; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Swelling (2091)
Event Type  Injury  
Manufacturer Narrative
Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.
 
Event Description
It was reported that patient underwent left and right partial knee arthroplasties on (b)(6) 2011.Subsequently, patient experienced swelling in left knee.No further information has been provided.
 
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Brand Name
OXF ANAT BRG LT LG SIZE 5 PMA
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
BIOMET UK LTD
waterton industrial estate
bridgend CF31 3XA
UK  CF31 3XA
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 Key5522636
MDR Text Key41042266
Report Number0001825034-2016-01004
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PP010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Reporter Occupation Physician
Type of Report Initial
Report Date 02/23/2016
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 Date03/31/2013
Device Model NumberN/A
Device Catalogue Number159556
Device Lot Number1494191
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/23/2016
Initial Date FDA Received03/24/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/28/2008
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) Required Intervention;
Patient Age84 YR
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