UNKNOWN KNEE TIBIAL TRAY UNK KNEE TIBIAL TRAY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2018-07-19 for UNKNOWN KNEE TIBIAL TRAY UNK KNEE TIBIAL TRAY manufactured by Depuy Orthopaedics, Inc. 1818910.

Event Text Entries

[114466469] (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10


[114466530] (b)(6). Clinical database notification email received indicating revision due to aseptic loosening of the femoral and tibial component. Doi: not provided; dor: (b)(6) 2018; (left knee). Femoral, tibial and insert components revised. Cement manufacturer not provided.
Patient Sequence No: 1, Text Type: D, B5


[130235809]
Patient Sequence No: 1, Text Type: N, H10


[130666852] Product complaint # : (b)(4). The implant associated with this report was not returned. 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. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1818910-2018-64821
MDR Report Key7703472
Report SourceHEALTH PROFESSIONAL,STUDY
Date Received2018-07-19
Date of Report2018-06-25
Date of Event2018-06-21
Date Mfgr Received2018-12-05
Date Added to Maude2018-07-19
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 ContactMS. KARA DITTY-BOVARD
Manufacturer Street1210 WARD AVENUE
Manufacturer CityWEST CHESTER PA 19380XXXX
Manufacturer CountryUS
Manufacturer Postal19380XXXX
Manufacturer Phone6103142063
Manufacturer G1DEPUY INT'L LTD. 8010379
Manufacturer StreetST ANTHONYS ROAD
Manufacturer CityLEEDS IN 465820988
Manufacturer CountryUS
Manufacturer Postal Code465820988
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN KNEE TIBIAL TRAY
Generic NameKNEE TIBIAL TRAY
Product CodeJJW
Date Received2018-07-19
Catalog NumberUNK KNEE TIBIAL TRAY
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-07-19

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