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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD OXF UNI TIB TRAY SZ D RM PMA; PROSTHESIS, KNEE

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BIOMET UK LTD OXF UNI TIB TRAY SZ D RM PMA; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Malposition of Device (2616)
Patient Problem No Code Available (3191)
Event Date 06/12/2015
Event Type  Injury  
Event Description
It was reported patient underwent a right partial knee arthroplasty on (b)(6) 2014.Subsequently, the patient was revised on (b)(6) 2015 due to the tibial baseplate overhanging anteriorly.All components were removed and replaced with a total knee system.
 
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.There are warnings in the package insert that state that this type of event can occur: "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.".
 
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Brand Name
OXF UNI TIB TRAY SZ D RM PMA
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
BIOMET UK LTD
waterlon industrial estate
bridend, south wales 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 Key4896543
MDR Text Key6068529
Report Number0001825034-2015-02857
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 Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 06/12/2015
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 Date02/29/2024
Device Model NumberN/A
Device Catalogue Number154725
Device Lot Number146290
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/12/2015
Initial Date FDA Received07/07/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2014
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) Hospitalization; Required Intervention;
Patient Age60 YR
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