IBP ULNA LEFT STD INTLK N/A 114368

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-19 for IBP ULNA LEFT STD INTLK N/A 114368 manufactured by Biomet Uk Ltd..

Event Text Entries

[139162894] (b)(4). Concomitant medical products: custom lt ibp med humeral comp, catalog #: cp560539, lot #: 750420. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[139162895] Elbow revision due to unknown reasons.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002806535-2019-00293
MDR Report Key8431468
Report SourceHEALTH PROFESSIONAL
Date Received2019-03-19
Date of Report2019-08-28
Date of Event2012-05-16
Date Mfgr Received2019-08-25
Device Manufacturer Date1997-06-13
Date Added to Maude2019-03-19
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 ContactMS. CHRISTINA ARNT
Manufacturer Street56 E. BELL DR.
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1BIOMET UK LTD.
Manufacturer StreetWATERTON INDUSTRIAL ESTATES
Manufacturer CityBRIDGEND CF313XA
Manufacturer CountryUK
Manufacturer Postal CodeCF31 3XA
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameIBP ULNA LEFT STD INTLK
Generic NamePROSTHESIS, ELBOW
Product CodeJDB
Date Received2019-03-19
Model NumberN/A
Catalog Number114368
Lot Number221552
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerBIOMET UK LTD.
Manufacturer AddressWATERTON INDUSTRIAL ESTATES BRIDGEND CF313XA UK CF31 3XA


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2019-03-19

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