K-15 PORK 71425303Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556732960), received between Sep 25, 2023 and Jul 29, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (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.

• InjuryJul 29, 2024Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED A FRACTURE OF THE MEDIAL TIBIAL PLATEAU, WHICH CAUSED ENOUGH MOTION FOR THE POROUS TIBIA BSEPLATE W/JRNY LOCK SZ3 RT DEVICE TO NOT GROW IN. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE DEVICE WAS REMOVED. CURRENT HEALTH STATUS OF PATIENT AND FURTHER DETAILS ARE UNKNOWN AT THIS MOMENT.

  Patient problems: Insufficient Information

  MAUDE report 19850233 ↗
• InjurySep 25, 2023Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED A LOOSENING OF THE POROUS TIBIA BSEPLATE W/JRNY LOCK SZ3 RT. THIS INCIDENT WAS DETERMINED VIA X-RAYS. A REVISION SURGERY HAS BEEN SCHEDULED BUT THE DATE STILL UNKNOWN. CURRENTLY THE PATIENT COMPLAINS OF PERSISTENT KNEE PAIN.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 17813587 ↗

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