FDA.reportPublic FDA data

MAUDE MDR 9824300

MDR report key
9824300
Report number
3009532798-2020-00010
Event key
0
Event type
3
Date of event
2019-12-18
Date received
2020-03-12
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
1HUMERISSHOUDLER PROTHESISFX SOLUTIONSHSD105-3613L2569R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1201. H; 2. R

Event Narratives#

D

Patient 1

SURGERY WAS DELAYED FOR AN ADDITIONAL FOUR HOURS. SURGEON DECISION TO SWITCH FROM ANATOMIC TO REVERSE AFTER BENDING PERIPHERAL PEGS ON GLENOID. DIFFICULTY ENGAGING BASEPLATE WITH 36 ECCENTRIC GLENOSPHERE WITH SCREW. DIFFICULTY WITH 36 CENTERED GLENOSPHERE WITH SCREW AND SIZE 12 STEM AND 36/+3 HUMERAL CUP, DUE TO STEM SPINNING OUT WHEN REDUCED. TRIED SIZE 16 STEM AND 36/+6 HUMERAL CUP, BUT CONTINUED TO DISLOCATE AFTER REDUCTION. SIZE 18 STEM, REVERSED ADAPTER FOR +9MM, 40/+3 HUMERAL CUP, AND 40 ECCENTRIC GLENOSPHERE WITH SCREW IMPLANTED SUCCESSFULLY.