inforMED
MalfunctionLTO

CEMENTRALIZER 10.5

Received Aug 18, 1999 · Event occurred Jul 19, 1999

Report 1818910-1999-00115 · MDR key 236423

Device

Generic name

Total Hip Prosthesis

Model number

NA

Catalog number

137638000

Lot number

S82JD1011

Product problems

  • Component(s), broken
  • Device, or device fragments remain in patient
  • Replace
  • Fitting Problem

Patient

UNKNOWN

  • Surgery, prolonged
  • Unknown (for use when the patient's condition is not known)
  • Surgical procedure, additional

Narrative

Description of Event or Problem

DURING A TOTAL HIP SURGERY; THE CEMENTRALIZER SHEARED OFF AND THE FEMORAL COMPONENT COULDN'T BE SEATED. SURGEON HAD TO REMOVE THE FEMORAL COMPONENT. THE CEMENTRALIZER WAS LEFT IN THE PT. SOME OF THE BONE CEMENT HAD ALREADY HARDENED. THEY DID ADDITIONAL WORK TO GET A NEW FEMORAL COMPONENT AND CEMENTRALIZER PUT IN. THERE WAS NO PT INJURY; BUT A DELAY IN SURGERY.

Remedial action

  • Other