UNKNOWN NEXGEN KNEE COMPONENT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2013-05-15 for UNKNOWN NEXGEN KNEE COMPONENT manufactured by Zimmer, Inc..

Event Text Entries

[19732727] It is reported that the patient received a right knee implant in 2010 and was revised due to an unknown reason. It is also reported that the patient's leg was later amputated.
Patient Sequence No: 1, Text Type: D, B5


[19833861] Information was received from a consumer who is not required to complete form 3500a. Evaluation summary: neither surgical notes nor x-rays were provided; therefore, fit and orientation could not be evaluated. Patient factors that may effect the performance of the components such as bone quality, activity level or type of activity (low impact vs. High impact) are unknown. A definitive root cause cannot be determined with the information provided. Evaluation codes: review of the device history records was not possible as the product and/or lot numbers required for retrieval were unavailable. It is not suspected that the product failed to meet specifications. The investigation could not verify or identify any evidence of product contribution to the reported problem. Based on the available information, the need for corrective action is not indicated. Should additional substantive information be received, the complaint will be reopened. Zimmer, inc. Considers the investigation closed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1822565-2013-00802
MDR Report Key3129548
Report Source04,07
Date Received2013-05-15
Date of Report2013-04-19
Date Mfgr Received2013-04-19
Date Added to Maude2013-05-28
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 ContactKEVIN ESCAPULE
Manufacturer StreetP.O. BOX 708
Manufacturer CityWARSAW IN 465810708
Manufacturer CountryUS
Manufacturer Postal465810708
Manufacturer Phone8006136131
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN NEXGEN KNEE COMPONENT
Generic NameKNEE PROSTHESIS
Product CodeHSA
Date Received2013-05-15
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER, INC.
Manufacturer AddressP.O. BOX 708 WARSAW IN 46581070 US 46581 0708


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2013-05-15

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