NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE FEMORAL COMPONENT OPTION 00588001502

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2008-02-29 for NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE FEMORAL COMPONENT OPTION 00588001502 manufactured by Zimmer, Inc..

Event Text Entries

[18107000] It is reported that the device was implanted in 2006. The device was revised in 2008, due to the locking mechanism and locking pin fracturing.
Patient Sequence No: 1, Text Type: D, B5


[18348209] This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1822565-2008-00071
MDR Report Key1005361
Report Source01,05,08
Date Received2008-02-29
Date of Report2008-01-31
Date of Event2008-01-23
Date Facility Aware2008-01-31
Report Date2008-01-31
Date Mfgr Received2008-01-31
Device Manufacturer Date2005-07-01
Date Added to Maude2008-03-10
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 FDA3
Event Location3
Manufacturer ContactANN RECKTENWALL
Manufacturer StreetP.O. BOX 708
Manufacturer CityWARSAW IN 465810708
Manufacturer CountryUS
Manufacturer Postal465810708
Manufacturer Phone5743728028
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameNEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE FEMORAL COMPONENT OPTION
Generic NameKNEE PROSTHESIS
Product CodeHRZ
Date Received2008-02-29
Returned To Mfg2008-02-15
Model NumberNA
Catalog Number00588001502
Lot Number60240010
ID NumberNA
Device Expiration Date2015-07-31
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Age2 YR
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedV
Device Sequence No1
Device Event Key975477
ManufacturerZIMMER, INC.
Manufacturer AddressP.O. BOX 708 WARSAW IN 465810708 US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2008-02-29

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