CEMENTRALIZER 12.0
Received Dec 5, 2018 · Event occurred Nov 7, 2018
Report 1818910-2018-77222 · MDR key 8132959
Device
Generic name
Hip Miscellaneous : Cement Centralizer/plug
Manufacturer
Depuy Orthopaedics Inc UsCatalog number
137621000
Lot number
J04N00
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).
Description of Event or Problem
CLINICAL ADVERSE EVENT RECEIVED FOR FOOT DROP.
Additional Manufacturer Narrative
PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. UPDATE 21-DEC-2018: INVESTIGATION RE-OPENED UPON RECEIPT OF ADDITIONAL INFORMATION. THE NEW INFORMATION DOES NOT AFFECT THE PREVIOUS INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.