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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BMET REGENX PRI TIBIAL TRAY 79MM PROTHESIS, KNEE

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BIOMET ORTHOPEDICS BMET REGENX PRI TIBIAL TRAY 79MM PROTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Inadequacy of Device Shape and/or Size (1583); Device Slipped (1584)
Patient Problems Unspecified Infection (1930); Pain (1994)
Event Date 07/17/2015
Event Type  Injury  
Event Description

It was reported that patient underwent an initial left total knee arthroplasty on (b)(6) 2015. Subsequently, patient was revised on (b)(6) 2015 due to infection, pain, leg length discrepancy, and loosening. All components were removed and replaced with competitor products.

 
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 2 states, "early or late postoperative infection and/or allergic reaction. " number 4 states, "loosening, migration, or fracture of the implants can occur due to loss of fixation, trauma, malalignment, malposition, non-union, bone resorption and/or excessive unusual and/or awkward movement and/or activity. " number 15 states, "postoperative pain. " review of sterilization certification confirms device was sterilized in accordance with iso 11137-2. This report is number 1 of 5 mdrs filed for the same event (reference 1825034-2015-03425 / 03429).

 
Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 2 states, "early or late postoperative infection and/or allergic reaction. " number 4 states, "loosening, migration, or fracture of the implants can occur due to loss of fixation, trauma, malalignment, malposition, non-union, bone resorption and/or excessive unusual and/or awkward movement and/or activity. " number 12 states, "valgus-varus deformity. " number 15 states, "postoperative pain. " this report is number 1 of 5 mdrs filed for the same event (reference 1825034-2015-03425 / 03429).

 
Event Description

It was reported that patient underwent an initial left total knee arthroplasty on (b)(6) 2015. Subsequently, patient was revised on (b)(6) 2015 due to infection, pain, leg length discrepancy, and loosening. All components were removed and replaced with competitor products. Additional information received in operative report noted during the procedure: no infection present; no polys; mild, chronic inflammation; clear fluid; synovial thickening; no purulence; femoral and patellar components were well fixed and well positioned; tibial component in a varus position with minimal bony ingrowth; tibial implant uncemented.

 
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Brand NameBMET REGENX PRI TIBIAL TRAY 79MM
Type of DevicePROTHESIS, 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 Key4960706
MDR Text Key6037533
Report Number0001825034-2015-03425
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK080361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/18/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/03/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL NumberN/A
Device Catalogue Number141275
Device LOT Number793570
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/29/2014
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 TREATMENT DATA
Date Received: 08/03/2015 Patient Sequence Number: 1
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