PFCSIGMA C/R FEM CEM LFTSZ3DNI 969999

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 2020-03-31 for PFCSIGMA C/R FEM CEM LFTSZ3DNI 969999 manufactured by Depuy Orthopaedics Inc Us.

Event Text Entries

[187716600] (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


[187716601] Clinical adverse event received for quad tendon tear. Event is serious and is considered severe. Event is possibly related to both device and procedure. Date of implantation: (b)(6) 2019. Date of event (onset): (b)(6) 2020. (right knee). Treatment: surgical quadriceps tendon repair.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-09714
MDR Report Key9903345
Report SourceHEALTH PROFESSIONAL,STUDY
Date Received2020-03-31
Date of Report2020-03-13
Date of Event2020-01-29
Date Mfgr Received2020-03-13
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone6107428552
Manufacturer G1DEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Street700 ORTHOPAEDIC DR.
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal Code465810988
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePFCSIGMA C/R FEM CEM LFTSZ3DNI
Generic NameKNEE INSTRUMENT : DNI
Product CodeJWH
Date Received2020-03-31
Catalog Number969999
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS INC US
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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