FDA.reportPublic FDA data

MAUDE MDR 9785327

MDR report key
9785327
Report number
3009532798-2020-00003
Event key
0
Event type
3
Date of event
2019-12-09
Date received
2020-03-04
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
1HUMERISSHOULDER PROTHESISFX SOLUTIONSHSD109-4520M2995R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-0401. H; 2. R

Event Narratives#

D

Patient 1

PATIENT'S SECOND REVISION SURGERY, DUE TO BREAKAGE OF TWO STANDARD SCREWS ON GLENOID SIDE. SURGEON EXPLANTED ALL GLENOID COMPONENTS AND REPLACED WITH THOSE FROM A DIFFERENT MANUFACTURER. ADDITIONALLY, SURGEON UPSIZED THE HUMERAL CUP. PATIENT'S PRIMARY SURGERY WAS (B)(6) 2018. PATIENT'S FIRST REVISION CONVERTED ANATOMIC SHOULDER TO A REVERSE DUE TO FAILING ROTATOR CUFF APPROXIMATELY 8 MONTHS LATER, AND WAS NOT PREVIOUSLY REPORTED.