VANGUARD SSK PSC TIBIAL BEARING S16X71/75 N/A 183846

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 2012-06-01 for VANGUARD SSK PSC TIBIAL BEARING S16X71/75 N/A 183846 manufactured by Biomet Orthopedics.

Event Text Entries

[2656964] Information received from an independent laboratory indicates that a patient underwent knee arthroplasty on (b)(6) 2010. It was further reported that the tibial bearing was revised approximately one year later due to loosening. No further information has been provided to date.
Patient Sequence No: 1, Text Type: D, B5


[9928650] 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 or excessive activity. " 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 additional details pertaining to event information are received, a follow up medwatch will be submitted to the fda. The following sections could not be completed with the limited information available: date of event - the date of the revision procedure is unknown, but was reported to have taken place approximately one year after initial implantation. Date explanted - unknown.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number0001825034-2012-00751
MDR Report Key2596145
Report Source00
Date Received2012-06-01
Date of Report2012-05-03
Date Mfgr Received2012-05-03
Device Manufacturer Date2007-12-12
Date Added to Maude2012-06-01
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 EAST BELL DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5743711021
Manufacturer G1BIOMET ORTHOPEDICS
Manufacturer Street56 EAST 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 NameVANGUARD SSK PSC TIBIAL BEARING S16X71/75
Generic NamePROSTHESIS, KNEE
Product CodeBSN
Date Received2012-06-01
Model NumberN/A
Catalog Number183846
Lot Number551980
ID NumberN/A
Device Expiration Date2012-12-31
OperatorPHYSICIAN
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMET ORTHOPEDICS
Manufacturer Address56 EAST BELL DRIVE WARSAW IN 46582 US 46582


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2012-06-01

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.