LATERAL ASSEMBLY, RADIAL STEM IMPLANT, SIZE 4 3100003

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-13 for LATERAL ASSEMBLY, RADIAL STEM IMPLANT, SIZE 4 3100003 manufactured by Stryker Gmbh.

Event Text Entries

[130311358] Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device was not received.
Patient Sequence No: 1, Text Type: N, H10


[130311359] Patient was lifting a box overhead, lateral radial head dislodged from stem. Both head and stem implants were explanted. Competitive product used as replacement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0008031020-2018-01057
MDR Report Key8162197
Date Received2018-12-13
Date of Report2019-02-21
Date of Event2018-11-15
Date Mfgr Received2019-01-24
Device Manufacturer Date2014-12-23
Date Added to Maude2018-12-13
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 ContactMR. ANNA JUSINSKI
Manufacturer Street325 CORPORATE DRIVE
Manufacturer CityMAHWAH NJ 07430
Manufacturer CountryUS
Manufacturer Postal07430
Manufacturer Phone2018315000
Manufacturer G1STRYKER GMBH
Manufacturer StreetBOHNACKERWEG 1 POSTFACH
Manufacturer CitySELZACH 2545
Manufacturer CountryCH
Manufacturer Postal Code2545
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameLATERAL ASSEMBLY, RADIAL STEM IMPLANT, SIZE 4
Generic NameELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS
Product CodeJDB
Date Received2018-12-13
Catalog Number3100003
Lot Number10187-L04
Device Expiration Date2019-12-31
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER GMBH
Manufacturer AddressBOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-12-13

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