SROM STM STD 36+12L 13X18 56-3618 563618

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 2020-03-05 for SROM STM STD 36+12L 13X18 56-3618 563618 manufactured by Depuy Orthopaedics Inc Us.

Event Text Entries

[187547191] (b)(4). Initial reporter occupation: lawyer. 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


[187547192] After review of medical records, the patient was revised to address metallosis, pain, elevated metal ion levels and osteolysis. Intraoperatively, tan appearing synovial fluid consistent with metallosis was obtained. Discharge summary notes history of swelling and marked loss of function. Doi: (b)(6) 2009; dor: (b)(6) 2017 (left hip).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-07014
MDR Report Key9794638
Report SourceCONSUMER,OTHER
Date Received2020-03-05
Date of Report2020-02-18
Date of Event2017-04-26
Date Mfgr Received2020-02-18
Device Manufacturer Date2009-05-29
Date Added to Maude2020-03-05
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 DRIVE
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 13X18
Generic NameS-ROM HIP SYSTEM : HIP FEMORAL STEM
Product CodeMRA
Date Received2020-03-05
Model Number56-3618
Catalog Number563618
Lot Number2932974
Device Expiration Date2014-05-31
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 2020-03-05

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