FDA.reportPublic FDA data

MAUDE MDR 7754454

MDR report key
7754454
Report number
0001825034-2018-06031
Event key
0
Event type
3
Date of event
2018-02-28
Date received
2018-08-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. CHRISTINA ARNT
Address
56 E. BELL DR. WARSAW IN 46582 US
Phone
574-574-5745
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COMPREHENSIVE REVERSE E1 HUMERAL BEARINGPROSTHESIS, SHOULDERZIMMER BIOMET, INC.PAON/AEP-115393734030R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-0601. H; 2. R

Event Narratives#

N

Patient 1

(B)(4). CONCOMITANT MEDICAL PRODUCTS: 115310, COMP RVRS SHLDR GLNSP STD 36MM 129260; 113629, COMP PRIMARY STEM 9MM MINI, 979660; 115370, COMP RVS TRAY CO 44MM, 596600; 010000589, COMP RVRS 25MM BSPLT HA+ADPTR, 592930;? 180558, COMP NLK SCR 3.5HEX 4.75X20 ST, 860890; 180560, COMP NLK SCR 3.5HEX 4.75X30 ST, 018440; 115397, COMP RVS CNTRL 6.5X35MM ST/RST, 569900. THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2018 -06009; 0001825034 -2018 -06014; 0001825034 -2018 -06025; 0001825034 -2018 -06029.

D

Patient 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVERSE TOTAL SHOULDER ARTHROPLASTY, AND WAS REVISED DUE TO UNKNOWN REASONS APPROXIMATELY FIVE (5) MONTHS POST-IMPLANTATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.