FDA.reportPublic FDA data

MAUDE MDR 9860074

MDR report key
9860074
Report number
0001822565-2020-01008
Event key
0
Event type
3
Date of event
2020-02-28
Date received
2020-03-20
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
1UNKNOWN GLENOSPHEREPROSTHESIS, SHOULDERZIMMER BIOMET, INC.HSDNININIR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2001. H; 2. R

Event Narratives#

N

Patient 1

(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2020 - 01007.

D

Patient 1

IT WAS REPORTED THAT A PATIENT UNDERWENT SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE APPROXIMATELY 7 YEARS AGO. SUBSEQUENTLY, PATIENT WAS REVISED DUE TO THE SCREW AND HEAD DISENGAGING. THE PROCEDURE TOOK APPROXIMATELY 30 MINUTES LONGER TO REMOVE THE SCREW FROM THE ARM. NEW SCREW AND HEAD WERE IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.