MAX DCM CONSTRAINED TIBIAL BEARING 10X71/75 N/A 11-146750

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-05-31 for MAX DCM CONSTRAINED TIBIAL BEARING 10X71/75 N/A 11-146750 manufactured by Biomet Orthopedics.

Event Text Entries

[2658379] Information received from an independent laboratory indicates that a patient underwent knee arthroplasty on (b)(6) 2006. It was further reported that the tibial bearing was revised approximately 3. 1 years later for an unknown reason. No further information has been provided to date.
Patient Sequence No: 1, Text Type: D, B5


[9888202] 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 various warnings and precautions in the package insert including: "improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components. " and "excessive activity, trauma and weight gain have been implicated with premature failure of the implant by loosening, fracture and/or wear. " information received from the independent laboratory was very limited in nature. Follow up attempts to obtain more detailed information have been unsuccessful to date. In the event that the additional details pertaining to event information are received, a follow up medwatch will be submitted to the fda. The date of the revision procedure is unknown, but was reported to have taken place approximately 3. 1 years after initial implantation. Date explanted - unknown.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number0001825034-2012-00732
MDR Report Key2594576
Report Source00
Date Received2012-05-31
Date of Report2012-05-03
Date Mfgr Received2012-05-03
Device Manufacturer Date2005-09-02
Date Added to Maude2012-05-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMS. ANGELA DICKSON
Manufacturer Street56 E. BELL DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5743711021
Manufacturer G1BIOMET ORTHOPEDICS
Manufacturer Street56 E. BELL DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal Code46582
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameMAX DCM CONSTRAINED TIBIAL BEARING 10X71/75
Generic NamePROSTHESIS, KNEE
Product CodeBSN
Date Received2012-05-31
Model NumberN/A
Catalog Number11-146750
Lot Number835450
ID NumberN/A
Device Expiration Date2010-08-31
OperatorPHYSICIAN
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMET ORTHOPEDICS
Manufacturer Address56 E. BELL DRIVE WARSAW IN 46582 US 46582


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2012-05-31

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