CEMENTRALIZER 10.5
Received Nov 2, 2016 · Event occurred Oct 31, 2016
Report 1818910-2016-30673 · MDR key 6074053
Device
Generic name
Hip Other Implant
Manufacturer
Depuy Cmw ¿ Reg. # 9610921Catalog number
137638000
Lot number
594227
Product problems
- Loss of or Failure to Bond
- Loss of or Failure to Bond
Patient
75 YR
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. 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
PATIENT WAS REVISED TO ADDRESS FEMORAL STEM LOOSENING. LOOSENING OCCURRED AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED AT PRIMARY.
Additional Manufacturer Narrative
EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.