UNKNOWN PCA HOMEDICA BASEPLATE
Received Dec 20, 2011 · Event occurred Dec 5, 2011
Report 2249697-2011-01802 · MDR key 2392058
Device
Generic name
Implant
Manufacturer
Stryker Orthopaedics MahwahModel number
NACatalog number
UNK
Lot number
UNK
Product problems
- Insufficient Device Problem Information
Patient
59 YR
- No Code Available
Narrative
Additional Manufacturer Narrative
THE UNKNOWN PCA HOWMEDICA POLY AND UNKNOWN PCA HOWMEDICA FEMORAL COMPONENT WERE ALSO LISTED IN THIS REPORT. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S REVISION. AN EVALUATION OF THE DEVICES CANNOT BE PERFORMED AS THE DEVICES WERE NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICES REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
IT WAS REPORTED THAT, "I HAVE NO DETAILS ABOUT PATIENT OR CASE OTHER THAN WHAT I LISTED ABOVE. I WAS NOT PRESENT FOR THE REVISION AND MY ONLY INVOLVEMENT WAS WHEN ASKED IF WE COULD GET COMPONENTS FOR AN IMPLANT THAT WAS OVER 20 YEARS OLD."
Remedial action
- Other