K-15 PORK 71425306Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556732991), received between Oct 31, 2022 and Oct 31, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Osseointegration Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT, AFTER TKA WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ONGOING PAIN. X-RAYS CONFIRMED A GAP ON THE LATERAL SIDE OF THE TIBIA. THE TIBIA WAS NOT FULLY SEATED AND NO BONY INGROWTH WAS OBSERVED. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2022, IN WHICH THE FEMUR, TIBIA, AND INSERT WERE EXCHANGED. AS THERE WAS NO ISSUE WITH THE PATELLA, IT WAS LEFT IN THE PATIENT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 15705366 ↗

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