UNK ZIMMER 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 2013-07-24 for UNK ZIMMER KNEE COMPONENT manufactured by Zimmer, Inc..

Event Text Entries

[3610118] It is reported that the patient is experiencing a stiff knee, and range of motion if maybe 50% in her knee.
Patient Sequence No: 1, Text Type: D, B5


[10963818] Evaluation summary: surgical notes were not provided. X-rays were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique. Rehabilitation protocol and adherence thereto is unknown. A definitive root cause cannot be determined with the information provided. Evaluation: 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 Number1822565-2013-01137
MDR Report Key3249962
Report Source04,07
Date Received2013-07-24
Date of Report2013-06-24
Date Mfgr Received2013-06-24
Date Added to Maude2013-07-29
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 NameUNK ZIMMER KNEE COMPONENT
Generic NameKNEE PROSTHESIS
Product CodeHSA
Date Received2013-07-24
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. Other 2013-07-24

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