inforMED
MalfunctionKWE

WRIGHT-MEDICAL

Received May 22, 2002 · Event occurred Sep 10, 2001

Report 398154 · MDR key 398154

Device

Generic name

Titanium Basal Thumb Implant

Model number

*

Catalog number

428-3004

Lot number

027A049935

Product problems

  • Material Disintegration
  • Explanted
  • Loose

Patient

53 YR

  • Inflammation
  • Pain
  • Surgical procedure

Narrative

Description of Event or Problem

THE PROBLEM IN ONE OF A POSSIBLE IMPLANT PT REACTION. IN SUMMARY, A CONVEX CONDYLAR TITANIUM IMPLANT FOR THUMB SUPRAMETACARPAL OSTEOARTHRITIS WAS IMPLANTED. PT DID WELL POST-OPERATIVELY BUT WITHIN 6 MONTHS WAS HAVING RECURRING PAIN. THIS PAIN PROGRESSED AND X-RAY STARTED TO SHOW LUCENCY AROUND THE IMPLANT. IT FINALLY HAD TO BE REMOVED BECAUSE OF PERSISTENT PAIN BUT WAS THOUGHT TO BE DONE TO IMPLANT LOOSENING. AT RE-OPERATION, SIGNIFICANT INFLAMMATORY DEBRIS AND TISSUE WAS SEEN WITH METALLIC DEBRIS AS WELL.