UNKNOWN BIGLIANI/FLATOW HUMERAL COMPONENT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-03-11 for UNKNOWN BIGLIANI/FLATOW HUMERAL COMPONENT manufactured by Zimmer Inc.

Event Text Entries

[40150574] Information was received via published literature. Please reference literature at the following location: http://www. Jshoulderelbow. Org/article/s1058-2746(12)00182-6/pdf (b)(4). This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


[40150575] It is reported that posterior subluxation was noted radiographically for one patient.
Patient Sequence No: 1, Text Type: D, B5


[49964836] No devices or photos were received; therefore the condition of the components is unknown. Device history records cannot be reviewed since the part and lot numbers are unknown. These devices are used for treatment. Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique. Product history search cannot be completed and compatibly cannot be verified since the part and lot numbers are unknown. Patient? S adherence to rehabilitation protocol is unknown. A definite root cause cannot be determined with the information provided.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1822565-2016-00618
MDR Report Key5495024
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2016-03-11
Date of Report2016-02-15
Date Mfgr Received2016-07-07
Date Added to Maude2016-03-11
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 ContactKEVIN ESCAPULE
Manufacturer StreetP.O. BOX 708
Manufacturer CityWARSAW IN 465810708
Manufacturer CountryUS
Manufacturer Postal465810708
Manufacturer Phone8006136131
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN BIGLIANI/FLATOW HUMERAL COMPONENT
Generic NameSHOULDER PROSTHESIS
Product CodeKWR
Date Received2016-03-11
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER INC
Manufacturer AddressP.O. BOX 708 WARSAW IN 465810708 US 465810708


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-03-11

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