DXTEND GLENOSPHERE STD D38MM 130760138

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 2020-03-04 for DXTEND GLENOSPHERE STD D38MM 130760138 manufactured by Depuy France Sas - 3003895575.

Event Text Entries

[181969952] (b)(4). 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


[181969953] (b)(6) hospital, (b)(6) 2020; surgeon performed a rtsr on this patient on (b)(6) 2015 in (b)(6) hospital for fracture. No notes available. On (b)(6) 2020: revision was for "significant notching" as reported by surgeon. He also said "it is because the metaglene has been placed too superiorly". Glenosphere and humeral poly removed and replaced with a lateralised glenosphere (38 +4 ecc) and a 38 + 3 std poly.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-06760
MDR Report Key9785769
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-04
Date of Report2020-02-17
Date of Event2020-02-17
Date Mfgr Received2020-03-27
Device Manufacturer Date2015-07-01
Date Added to Maude2020-03-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street700 ORTHOPAEDIC DR.
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone6107428552
Manufacturer G1DEPUY FRANCE SAS 3003895575
Manufacturer Street7 ALLEE IRENE JOLIOT-CURIE B.P. 256
Manufacturer CitySAINT PRIEST CEDEX 69801
Manufacturer CountryFR
Manufacturer Postal Code69801
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDXTEND GLENOSPHERE STD D38MM
Generic NameDELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE
Product CodeHSD
Date Received2020-03-04
Model Number130760138
Catalog Number130760138
Lot Number5252692
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY FRANCE SAS - 3003895575
Manufacturer Address7 ALLEE IRENE JOLIOT-CURIE B.P. 256 SAINT PRIEST CEDEX 69801 FR 69801


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-04

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