FDA.reportPublic FDA data

MAUDE MDR 7946927

MDR report key
7946927
Report number
0001825034-2018-09194
Event key
0
Event type
3
Date of event
2017-03-05
Date received
2018-10-09
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
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 HUMERAL BEARINGPROSTHESIS, SHOULDERZIMMER BIOMET, INC.MJTN/AXL-115363884300R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-10-0901. H; 2. R

Event Narratives#

N

Patient 1

(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT CODE: PHX. UNIQUE IDENTIFIER (UDI) #: (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM # 115378, COMP RVS TRAY +10MM CO 44MM, LOT #905990. ITEM # 180550, COMP LK SCR 3.5HEX 4.75X15 ST, LOT # 331030. ITEM # 180554, COMP LK SCR 3.5HEX 4.75X35 ST, LOT # 028240. ITEM # 010000589, COMP RVRS 25MM BSPLT HA+ADPTR, LOT # 017540. ITEM # 115310, COMP RVRS SHLDR GLNSP STD 36MM, LOT # 961680. ITEM # 180550, COMP LK SCR 3.5HEX 4.75X15 ST, LOT # 135680. ITEM # 115396, COMP RVS CNTRL 6.5X30MM ST/RST, LOT # 391730. ITEM # 406669, STN PN THD TIP .125X2.5IN 2PK, LOT # 354400. ITEM # 113635, COMP PRIMARY STEM 15MM MINI, LOT # 231180. LEGAL NOTIFICATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-09193, 0001825034-2018-09195, 0001825034-2018-09196, 0001825034-2018-09197, 0001825034-2018-09198, 0001825034-2018-09199, 0001825034-2018-09200, 0001825034-2018-09201, 0001825034-2018-09202.

D

Patient 1

IT WAS REPORTED THAT APPROXIMATELY THREE (3) MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT A REVISION TO HAVE THE SHOULDER PROSTHESIS REMOVED WITH IRRIGATION AND DEBRIDEMENT AND THE PLACEMENT OF AN ANTIBIOTIC SPACER. IT IS FURTHER ALLEGED THAT THE PATIENT CONTINUED TO HAVE ANTIBIOTIC TREATMENT FOR INFECTION FROM THE 2ND REVISION, UNTIL PRESENT TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.