UNKNOWN HIP FEMORAL HEAD UNK HIP FEMORAL HEAD

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 2020-03-26 for UNKNOWN HIP FEMORAL HEAD UNK HIP FEMORAL HEAD manufactured by Depuy Orthopaedics Inc Us.

Event Text Entries

[188869123] (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. Investigation summary. No device associated with this report was received for examination. A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided. The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.
Patient Sequence No: 1, Text Type: N, H10


[188869124] Ppf and pfs received. Ppf alleged infection and dislocation with closed reduction after first revision. . Pfs alleges pain, weakness, instability and decreased range of motion after first revision. Doi: (b)(6) 2017. Dor: none reported. Right hip.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-09423
MDR Report Key9885715
Report SourceCONSUMER,OTHER
Date Received2020-03-26
Date of Report2020-03-09
Date Mfgr Received2020-03-05
Date Added to Maude2020-03-26
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 NameUNKNOWN HIP FEMORAL HEAD
Generic NameHIP FEMORAL HEAD
Product CodeKXA
Date Received2020-03-26
Catalog NumberUNK HIP FEMORAL HEAD
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 2020-03-26

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