inforMED
InjuryHSX

LINK SLED

Received Jul 10, 2026 · Event occurred Jul 1, 2025

Report 3004371426-2026-00054 · MDR key 25775260

Device

Generic name

Link Sled, Tibial Plateau Anatomical, Uhmwpe, Cocrmo Cemented, Metal-backed, Ø

Model number

15-2030/15

Catalog number

15-2030/15

Product problems

  • Fracture
  • Naturally Worn

Patient

69 YR · Female

  • Pain
  • Loss of Range of Motion

Narrative

Description of Event or Problem

FRACTURED SECURITY WIRE [CUSTOMER].

Additional Manufacturer Narrative

WE INITIAL RECEIVED THE COMPLAINT ON 05/27/2026. FURTHER INFORMATION AND CLINICAL DATA WERE REQUESTED. THE INFORMATION THAT LED TO THE DETERMINATION OF REPORTABILITY WAS MADE AVAILABLE ON 06/25/2026. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO DEVIATIONS. THE PRODUCT COMPLIES WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURE.