FDA.reportPublic FDA data

MAUDE MDR 9902642

MDR report key
9902642
Report number
0001825034-2020-01373
Event key
0
Event type
3
Date of event
2020-03-07
Date received
2020-03-31
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
1UNK BEARINGPROSTHESIS, EXTREMITIESZIMMER BIOMET, INC.KWSNIUNKNOWN BEARINGUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. O

Event Narratives#

N

Patient 1

(B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2020 - 01181. CONCOMITANT MEDICAL PRODUCTS: COMPR SRS IC SEG - 60MM; PART#211225; LOT#UNK. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

D

Patient 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A COMPREHENSIVE REVERSE SHOULDER CONSTRUCT APPROXIMATELY 4 WEEKS AGO. TWO DAYS POST-IMPLANTATION, A DISLOCATION WAS NOTICED. RETENTION SCREW/SET SCREWS WERE NOT USED. FOR THIS PATIENT, NO SRS STEM WAS USED, BUT THE PROXIMAL HUMERAL SRS COMPONENT DID REMAIN INTACT. REVISION SURGERY IS UNKNOWN AT THIS TIME, BUT WILL BE UPDATED ONCE IT'S BEEN SCHEDULED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.