InjuryNPJ
MAKO UKR X3 ONLAY INSERT SIZE 5 - 8 MM
Received May 4, 2026 · Event occurred Apr 1, 2026
Report 3005985723-2026-00215 · MDR key 25072041
Device
Generic name
Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polym
Manufacturer
Stryker Orthopaedics-mahwahCatalog number
180735-1-E
Lot number
KL2AXA
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
69 YR · Male
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THAT DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
THE FOLLOWING INFORMATION WAS PROVIDED: I&D OF A LM PKA WITH AN MCK TIBIAL INSERT EXCHANGE DUE TO INFECTION.