K-15 PORK 71425307Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556733004), received between Apr 19, 2022 and May 2, 2023 — classified as 2 injuries.

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.

• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2022, A REVISION SURGERY HAD TO BE PERFORMED ON (B)(6) 2023 DUE TO INSTABILITY AND PAIN. DURING THE REVISION SURGERY IT WAS FOUND THAT THE POROUS TIBIA BSEPLATE W/JRNY LOCK SZ7 RT DID NOT PRESENT FULLY INGROWN. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. FURTHER DETAILS ARE NOT AVAILABLE AT THIS MOMENT.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Joint Laxity; Pain

  MAUDE report 16857670 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCE AN INFECTION AFTER 6 WEEKS. THE ADVERSE EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2022 TO EXPLANT THE FEMUR, TIBIA, INSERT AND PATELLAR COMPONENTS. PATIENT'S CURRENT STATUS OF HEALTH IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 14147513 ↗