NOT COMMUNICATED
Received Feb 21, 2019 · Event occurred Nov 15, 2018
Report 3006946279-2019-00109 · MDR key 8357541
Device
Generic name
Not Communicated
Manufacturer
Biomet France S.a.r.l.Catalog number
NOT COMMUNICATED
Lot number
NOT COMMUNICATED
Product problems
- Infusion or Flow Problem
- Infusion or Flow Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTION HAS BEEN UPDATED : B5, G1-2, G4, H2, H3, H6, H10. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THEREFORE IT COULD NOT BE ANALYZED AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE MANUFACTURING QUALITY RECORD COULD NOT BE REVIEWED AS THE ITEM AND LOT NUMBER OF THE PRODUCT WERE NOT COMMUNICATED. THE REFERENCE AND BATCH OF THE SEMI-FINISHED PRODUCT OPTIPAC MONOMER POUCH 15ML, REFERENCE (B)(4), LOT NUMBER N166150 WERE PROVIDED. THE REVIEW OF THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT (B)(4) PRODUCTS OPTIPAC MONOMER POUCH 15ML, REFERENCE (B)(4), LOT NUMBER N166150 WERE MANUFACTURED ON 27 DECEMBER 2017. THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT THE SEMI-FINISHEDPRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO NON CONFORMITY OR DEVIATION WAS OBSERVED WHICH COULD BE LINKED TO THE EVENT DESCRIBED IN THE COMPLAINT. THE COMPLAINT REVIEW COULD NOT BE PERFORMED AS THE ITEM AND LOT NUMBER OF THE PRODUCT WERE NOT COMMUNICATED. WITH THE AVAILABLE INFORMATION, THE EXACT ROOT CAUSE OF THE EVENT COULD NOT 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
Description of Event or Problem
IT HAS BEEN REPORTED THAT THE MONOMER WAS NOT ENTERING INTO THE CEMENT SYSTEM. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Additional Manufacturer Narrative
(B)(4). (B)(6). THE DEVICE WAS NOT EVALUATED AS THE BATCH NUMBER WAS NOT COMMUNICATED AND THE PRODUCT WAS NOT RETURNED. THE DEVICE WILL NOT RETURNED TO THE MANUFACTURER. THEREFORE IT COULD NOT BE ANALYZED. THE DEVICE MANUFACTURING QUALITY RECORD COULD NOT BE REVIEWED AS THE ITEM AND LOT NUMBER OF THE PRODUCT WERE NOT COMMUNICATED. WITH THE AVAILABLE INFORMATION, THE EXACT ROOT CAUSE OF THE EVENT COULD NOT 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.
Description of Event or Problem
IT HAS BEEN REPORTED THAT THE MONOMER WAS NOT ENTERING INTO THE CEMENT SYSTEM.