K-15 PORK 71425324Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556733059), received between Dec 3, 2024 and Apr 23, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Implant subsidence” (1 report).

1 other recall cover devices cleared under the same FDA submission (K211221, K230653); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2025Implant subsidence; Implant subsidence

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED SINKING OF THE TIBIAL BASEPLATE AND DISCOMFORT. THE SURGEON BELIEVED THAT THE PATIENT'S STIFF JOINT, HAD CAUSED THE STRESS TO BE CONCENTRATED IN THE ANTERIOR TIBIA, WHICH WAS THE CAUSE OF THE SINKING. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH THE BASEPLATE WAS EXCHANGED TO JOURNEY TIBIAL BASEPLATE SIZE 2 AND GENESIS LONG STEM 12MM×150MM. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Loss of Range of Motion

  MAUDE report 21896148 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER PRIMARY TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED THE FEMUR TO BE LOOSE. IT WAS ACCOMPANIED BY PAIN AND STIFFNESS. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH ONE (1) POROUS TIBIA BASEPLATE W/JRNY LOCK SZ4 LT WAS EXPLANTED. PATIENT IS RECOVERING FROM SURGERY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 20833367 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211221, K230653. One submission often covers many models, so check the product and lot details in each record.

• Z-2621-2023 · Aug 31, 2023 · Open, Classified
  smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint