SROM STM STD 36+12L 15X20 56-3620 563620

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-11 for SROM STM STD 36+12L 15X20 56-3620 563620 manufactured by Depuy Orthopaedics Inc Us.

Event Text Entries

[182956757] (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


[182956758] Medical records received. After review of medical records, there was no revision reported. The patient was unable to undergo revision and is now deceased. Date of death or reason of death was not provided. Clinic visit on (b)(6) 2011 notes that the patient reports persistent pain and discomfort. Past workup indicates fluid and irregularity on the patient's recent mr scan. Clinic visit on (b)(6) 2011 indicates immobility and elevated cobalt level at 23. 2 ng/ml (23. 2 ug/l). Primary surgery notes indicate that the sleeve was left slightly proud upon impaction. Doi: (b)(6) 2007, dor: not revised (left hip).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-07453
MDR Report Key9818225
Report SourceCONSUMER,OTHER
Date Received2020-03-11
Date of Report2020-02-20
Date Mfgr Received2020-02-20
Device Manufacturer Date2006-11-06
Date Added to Maude2020-03-11
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 ContactKARA DITTY-BOVARD
Manufacturer Street700 ORTHOPAEDIC DR.
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone6107428552
Manufacturer G1DEPUY IRELAND 9616671
Manufacturer StreetLOUGHBEG, RINGASKIDDY CO.
Manufacturer CityCORK
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSROM STM STD 36+12L 15X20
Generic NameS-ROM HIP SYSTEM : HIP FEMORAL STEM
Product CodeMRA
Date Received2020-03-11
Model Number56-3620
Catalog Number563620
Lot Number2254343
Device Expiration Date2011-10-31
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 2020-03-11

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