FDA.reportPublic FDA data

MAUDE MDR 9835546

MDR report key
9835546
Report number
3009532798-2020-19051
Event key
0
Event type
3
Date of event
2019-02-06
Date received
2020-03-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. CEDRIC JOLY
Address
1663 RUE DE MAJORNAS VIRIAT, 01440 FR
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HUMELOCK IISHOULDER PROTHESISFX SOLUTIONSHSD311-0012B019R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1601. H; 2. R

Event Narratives#

N

Patient 1

THE EVENT TOOK PLACE OUTSIDE OF THE UNITED STATES (IN (B)(6)) AND WAS ASSOCIATED WITH A PRODUCT THAT IS ALSO CLEARED FOR THE MARKET WITHIN THE UNITED STATES.

D

Patient 1

REVISION SURGERY OCCURRED (B)(6) 2019 DUE TO PAIN. ALL THE COMPONENT PARTS OF THE PROTHESIS WERE REMOVED AND REPLACED BY A COMPETITOR'S PROTHESIS. PRIMARY SURGERY OCCURRED (B)(6) 2013.