MODULAR CATHCART BALL 49MM OD 1363-49-000 136349000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-23 for MODULAR CATHCART BALL 49MM OD 1363-49-000 136349000 manufactured by Depuy Orthopaedics Inc Us.

Event Text Entries

[188859764] (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


[188859765] The patient was revised to address unstable hip. Converted from a hemi hip to a total hip. No further information is available. Doi: (b)(6) 2019; dor: (b)(6) 2020; affected site: left hip.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-08928
MDR Report Key9868311
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-23
Date of Report2020-03-05
Date of Event2020-03-05
Date Mfgr Received2020-03-05
Device Manufacturer Date2019-02-27
Date Added to Maude2020-03-23
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 G1JJMSZ PLANT FOR STK. & N-STK.
Manufacturer StreetNO. 299, CHANGYANG STREET SUZHOU INDUSTRIAL PARK
Manufacturer CitySUZHOU, JIANGSU 215126
Manufacturer CountryCH
Manufacturer Postal Code215126
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMODULAR CATHCART BALL 49MM OD
Generic NameHEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI
Product CodeLZY
Date Received2020-03-23
Model Number1363-49-000
Catalog Number136349000
Lot NumberD19020623
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 2020-03-23

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