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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD OXF ANATOMIC BRG LT MD SIZE 3; PROSTHESIS, KNEE

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BIOMET UK LTD OXF ANATOMIC BRG LT MD SIZE 3; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Material Erosion (1214); Device Dislodged or Dislocated (2923)
Patient Problems Cyst(s) (1800); Joint Dislocation (2374)
Event Date 04/21/2014
Event Type  Injury  
Event Description
It was reported patient underwent partial knee arthroplasty on (b)(6) 2013.Subsequently, patient underwent a revision procedure on (b)(6) 2014 due to dislocation, wear and a cyst.
 
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: under possible adverse effects, number 5 states, "material sensitivity reactions." number 12 states, "dislocation and subluxation due to inadequate fixation, malalignment, malposition, excessive unusual and/or awkward movement and/or activity, trauma, weight gain, or obesity.Muscle and fibrous tissue laxity can also contribute to these conditions." number 15 states, "wear and/or deformation of articulating surfaces.".
 
Manufacturer Narrative
This follow-up report is being filed to relay corrected and additional information, which was unknown at the time of the initial medwatch.
 
Manufacturer Narrative
This follow-up report is being filed to relay corrected information and additional information, which was unknown at the time of the initial medwatch.Discarded.
 
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Brand Name
OXF ANATOMIC BRG LT MD SIZE 3
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
BIOMET UK LTD
bridgend, cf31 3xa CF31 3XA
UK  CF31 3XA
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 Key3825147
MDR Text Key4393087
Report Number0001825034-2014-04553
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,company representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 03/04/2016
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 Date06/30/2018
Device Model NumberN/A
Device Catalogue Number159547
Device Lot Number3023254
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/03/2014
Initial Date FDA Received05/21/2014
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received06/20/2014
03/31/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/02/2013
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 Age63 YR
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