SUMMIT POR TAPER SZ7 HI OFF 1570-11-135 157011135

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 2020-03-30 for SUMMIT POR TAPER SZ7 HI OFF 1570-11-135 157011135 manufactured by Depuy Orthopaedics Inc Us.

Event Text Entries

[186137100] (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


[186137101] After review of medical records, the patient was revised to address pain and elevated metal ions. There was corrosion of the trunnion and metal liner along with metal staining in the fluid, heterotrophic bone, decreased adls and decreased functional mobility. Doi: (b)(6) 2010, dor: (b)(6) 2019, (left hip).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-09614
MDR Report Key9899686
Report SourceCONSUMER,OTHER
Date Received2020-03-30
Date of Report2020-03-10
Date of Event2019-09-23
Date Mfgr Received2020-03-10
Device Manufacturer Date2010-07-07
Date Added to Maude2020-03-30
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 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 NameSUMMIT POR TAPER SZ7 HI OFF
Generic NameSUMMIT HIP STEM : HIP FEMORAL STEM
Product CodeLPH
Date Received2020-03-30
Model Number1570-11-135
Catalog Number157011135
Lot NumberE1JE11
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 2020-03-30

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