HIGH VISCOSITY BONE CEMENT
Received Sep 15, 2022 · Event occurred Mar 10, 2015
Report MW5112078 · MDR key 15438086
Device
Generic name
Bone Cement, Antibiotic
Manufacturer
Stryker / Howmedica Osteonics Corp.Model number
HIGH VISCOSITY CEMENTCatalog number
6195-1-001
Lot number
424BA86DV
Product problems
- Loss of or Failure to Bond
- Product Quality Problem
Patient
68 YR · Female
- Failure of Implant
- Failure of Implant
Narrative
Description of Event or Problem
THIS PATIENT HAD A TOTAL KNEE REPLACEMENT PERFORMED ON THE DATE INDICATED. THE KNEE FAILED MUCH EARLIER THAN EXPECTED. WORK UP WAS NEGATIVE FOR INFECTION. THE RECORDS INDICATE THE ORIGINAL SURGERY WAS DONE USING STRYKER HIGH VISCOSITY BONE CEMENT FOR THE KNEE REPLACEMENT SURGERY. THE PATIENT HAD TO HAVE REVISION SURGERY AS INDICATED. THE FINDINGS AT TIME OF SURGERY WERE CLASSIC FOR A CEMENT FAILURE IN THAT THE CEMENT WAS NOT BONDED OR ADHERENT TO THE IMPLANTS BUT WAS AFFIXED TO THE BONE. THIS CASE IS ONE OF MANY CASES OF FAILURE AFTER 1.5-2.5 YEARS WHEN USING THIS PRODUCT. FDA SAFETY REPORT ID# (B)(4).