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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS OXF PKS ANAT MEN BEARING UHMWPE LT MED SZ 4; PROSTHESIS, KNEE

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BIOMET ORTHOPEDICS OXF PKS ANAT MEN BEARING UHMWPE LT MED SZ 4; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Scar Tissue (2060); No Code Available (3191)
Event Date 01/19/2016
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 a partial knee arthroplasty on (b)(6) 2014.Subsequently, a revision procedure was performed on (b)(6) 2016 due to unknown reasons.During the procedure, the polyethylene tibial bearing was removed and replaced.
 
Manufacturer Narrative
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
 
Event Description
It was reported that patient underwent a knee revision procedure approximately twenty (20) months post-implantation due to scar tissue.During the procedure, the tibial bearing was removed and replaced, and scar debridement occurred.
 
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Brand Name
OXF PKS ANAT MEN BEARING UHMWPE LT MED SZ 4
Type of Device
PROSTHESIS, KNEE
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
megan haas
56 e. bell drive
warsaw, IN 46582
5743726700
MDR Report Key5434906
MDR Text Key38170902
Report Number0001825034-2016-00505
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 health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/09/2016
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 Date12/31/2018
Device Model NumberN/A
Device Catalogue Number159548
Device Lot Number300760
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/20/2016
Initial Date FDA Received02/12/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/10/2013
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 Age67 YR
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