FDA.reportPublic FDA data

MAUDE MDR 9750519

MDR report key
9750519
Report number
0001822565-2020-00701
Event key
0
Event type
3
Date of event
2018-07-03
Date received
2020-02-25
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
1TM REVERSE BASE PLATEPROSTHESIS, SHOULDERZIMMER BIOMET, INC.KWTN/A0043490381163122393R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-2501. H; 2. R

Event Narratives#

N

Patient 1

(B)(4). X-RAYS WERE PROVIDED, BUT WERE FOUND TO BE NON-RELEVANT TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. IT WAS REPORTED HOWEVER, THAT THE SURGEON BELIEVES THE REASON FOR DEVICE FAILURE WAS DUE TO MEDICAL ISSUES WITH THE PATIENT. THE PATIENT HAS SOME PROBLEMS WITH HER LOWER EXTREMITIES AND IS RELIANT ON HER UPPER EXTREMITIES TO ASSIST IN STANDING FROM A SITTING POSITION. THE REPORTED EVENT CANNOT BE CONFIRMED FROM THIS INFORMATION. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. EVENT OCCURRED IN (B)(6).

D

Patient 1

IT WAS REPORTED THAT APPROXIMATELY 2.5 YEARS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO DEVICE MIGRATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.