UNKNOWN DEPUY TIBIAL TRAY UNK-KNEE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2013-08-26 for UNKNOWN DEPUY TIBIAL TRAY UNK-KNEE manufactured by 1818910 Depuy Orthopaedics, Inc..

Event Text Entries

[3590712] Patient was revised to address pain.
Patient Sequence No: 1, Text Type: D, B5


[11067047] This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.
Patient Sequence No: 1, Text Type: N, H10


[17775253] The device associated with this report were not returned. Review of the device history records and/or a lot specific complaint database search was not possible as the product and lot code required was not provided. Requests for additional investigational inputs were conducted. No additional information was obtained. The investigation could not verify or identify any product contribution to the reported event with the information provided. Based on the inability to identify root cause, the need for corrective action was not indicated. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1818910-2013-25018
MDR Report Key3307433
Report Source05,08
Date Received2013-08-26
Date of Report2013-08-14
Date of Event2013-08-14
Date Mfgr Received2013-08-14
Date Added to Maude2013-08-26
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 ContactSTACEY TRICK
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 46581
Manufacturer CountryUS
Manufacturer Postal46581
Manufacturer Phone5743714554
Manufacturer G11818910 DEPUY ORTHOPAEDICS, INC.
Manufacturer Street700 ORTHOPAEDIC DR.
Manufacturer CityWARSAW IN 46581
Manufacturer CountryUS
Manufacturer Postal Code46581
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN DEPUY TIBIAL TRAY
Generic NameTIBIAL TRAY
Product CodeHSH
Date Received2013-08-26
Catalog NumberUNK-KNEE
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
Manufacturer1818910 DEPUY ORTHOPAEDICS, INC.
Manufacturer Address700 ORTHOPAEDIC DR. WARSAW IN 46581 US 46581


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2013-08-26

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