CEMENTRALIZER 12.0
Received Sep 19, 2017 · Event occurred Aug 20, 2017
Report 1818910-2017-24928 · MDR key 6876365
Device
Generic name
Hip Femoral Head
Manufacturer
Depuy Orthopaedics, Inc.1818910Catalog number
137621000
Lot number
697774
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
81 YR
- Death
- Embolism
- Death
- Embolism
Narrative
Additional Manufacturer Narrative
IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem
IT WAS REPORTED THAT AFTER IMPLANTING THE REVISION PRODUCTS, THE PATIENT WAS CLOSED UP AND BEGAN EXPERIENCING PROBLEMS. THE PATIENT DIED IN ROOM. THE SURGEON LATER STATED THAT IT WAS PROBABLY DUE TO FAT EMBOLISM. COMPETITOR CEMENT WAS REPORTED TO BE USED DURING THE REVISION.
Additional Manufacturer Narrative
NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.