K-15 PORK 71425327Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556733080), received between Dec 27, 2021 and Sep 25, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Flaked” (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.

• InjurySep 25, 2023Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED A LOOSENING OF THE POROUS TIBIA BSEPLATE W/JRNY LOCK SZ7 LT. THIS INCIDENT WAS DETERMINED VIA X-RAYS. A REVISION SURGERY HAS BEEN SCHEDULED BUT THE DATE STILL UNKNOWN. CURRENTLY PATIENT COMPLAINS OF PERSISTENT PAIN IN KNEE.

  Patient problems: Inadequate Osseointegration; Radiolucent Lines

  MAUDE report 17813325 ↗
• InjuryDec 27, 2021Flaked; Flaked

  IT WAS REPORTED THAT, AS THE SURGEON IMPACTED THE TIBIA DURING A TKA SURGERY, HE NOTICED A FINE POWDER LIKE SUBSTANCE FALLING FROM UNDERSURFACE OF THE POROUS TIBIA BSEPLATE W/JRNY LOCK SZ7 LT. THE SURGERY WAS FINISHED, WITHOUT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED BEYOND THE ISSUE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13089682 ↗

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