inforMED
InjuryLTO

CEMENTRALIZER 15.0

Received Dec 3, 2009 · Event occurred Nov 7, 2009

Report 1818910-2009-06966 · MDR key 1552408

Device

Generic name

87lto

Model number

NA

Catalog number

137637000

Lot number

DH8MN1000

Product problems

  • Difficult to Insert

Patient

83 YR

  • Bone Fracture(s)
  • Surgery, prolonged

Narrative

Description of Event or Problem

DURING THE SURGERY THE CEMENTRALIZER STUCK IN THE CANAL, SURGEON WAS UNABLE TO FULLY SEAT THE STEM AND COULD NOT REMOVE IT. CEMENT HAD TO BE REMOVED AND A BONE FRACTURE OCCURRED DURING REMOVAL.

Additional Manufacturer Narrative

THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODE SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.