FDA.reportPublic FDA data

MAUDE MDR 9509160

MDR report key
9509160
Report number
3006946279-2019-00554
Event key
0
Event type
3
Date of event
2019-12-04
Date received
2019-12-23
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
1REFOBACIN BONE CEMENT R 1X40GBONE CEMENT, ANTIBIOTICBIOMET FRANCE S.A.R.L.MBB3003940001A750CD0910R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-12-230

Event Narratives#

N

Patient 1

(B)(4). REPORT SOURCE, FOREIGN, EVENT OCCURRED IN (B)(6). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THEREFORE IT COULD NOT BE ANALYZED. THE REVIEW OF THE DEVICE MANUFACTURING QUALITY RECORD INDICATE THAT 2.615 PRODUCTS DESIGNATION REFOBACIN BONE CEMENT R 40X1, REFERENCE (B)(4), BATCH A750CD0910 WERE MANUFACTURED ON (JULY 16, 2018). THE DEVICE MANUFACTURING QUALITY RECORD ((B)(4)) INDICATES THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO NON CONFORMITY OR DEVIATION WAS OBSERVED WHICH COULD BE LINKED TO THE COMPLAINT ISSUE (COMPLAINT CATEGORY INNER STERILE POUCH OPEN SEALING) EVENT DESCRIBED IN THE COMPLAINT. THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. ACCORDING TO AVAILABLE DATA, THE MOST PROBABLE ROOT CAUSE IS DUE TO PACKAGING ISSUE (SEALING PROCESS). CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS REPORTED ISSUE. 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.

D

Patient 1

IT IS FOUND THAT THE INNER STERILE PACKAGING IS OPENED DURING THE SURGERY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.