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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD CEMENTLESS TIBIA D LM UNKNOWN

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BIOMET UK LTD. OXFORD CEMENTLESS TIBIA D LM UNKNOWN Back to Search Results
Catalog Number US166576
Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 12/06/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products - oxf anat brg lt md size 3 pma, item 159547, lot 1546800, therapy date - device remains implanted, oxf twin peg cmntls fmrl md , item 161474, lot r2503468a, therapy date - device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2018-01197 and 3002806535-2018-01198. I.

 
Event Description

It has been reported by the clinical study group that the patient underwent an initial left knee arthroplasty. Subsequently, during a follow-up visit it was reported that the x-ray showed a radiolucent line under the tibial tray. The adverse event report stated that the severity was mild. No treatment was given.

 
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Brand NameOXFORD CEMENTLESS TIBIA D LM
Type of DeviceUNKNOWN
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK CF31 3XA
Manufacturer (Section G)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK CF31 3XA
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key8072997
MDR Text Key127203835
Report Number3002806535-2018-01199
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type STUDY
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/24/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/15/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUS166576
Device LOT NumberR3050478A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/27/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/14/2015
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

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