REFOBACIN BONE CEMENT R 1X40G 3003940001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-12-23 for REFOBACIN BONE CEMENT R 1X40G 3003940001 manufactured by Biomet France S.a.r.l..

Event Text Entries

[177941122] (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.
Patient Sequence No: 1, Text Type: N, H10


[177941123] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006946279-2019-00554
MDR Report Key9509160
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-12-23
Date of Report2020-03-31
Date of Event2019-12-04
Date Mfgr Received2020-03-23
Device Manufacturer Date2018-07-16
Date Added to Maude2019-12-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CHRISTINA ARNT
Manufacturer Street56 E. BELL DR.
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1BIOMET FRANCE S.A.R.L.
Manufacturer StreetPLATEAU DE LAUTAGNE BP75
Manufacturer CityVALENCE CEDEX 26903
Manufacturer CountryFR
Manufacturer Postal Code26903
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameREFOBACIN BONE CEMENT R 1X40G
Generic NameBONE CEMENT, ANTIBIOTIC
Product CodeMBB
Date Received2019-12-23
Catalog Number3003940001
Lot NumberA750CD0910
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMET FRANCE S.A.R.L.
Manufacturer AddressPLATEAU DE LAUTAGNE BP75 VALENCE CEDEX 26903 FR 26903


Patients

Patient NumberTreatmentOutcomeDate
10 2019-12-23

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