APEX Knee System KR-46000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841690117841), received between Nov 14, 2024 and Nov 14, 2024 — classified as 1 injury.

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 16, 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.

• InjuryNov 14, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE SURGERY ON (B)(6) 2024. DOCTOR WAS DRILLING THE TIBIA CANAL WITH A BOSS REAMER. IT WAS IDENTIFIED BY THE REP ATTENDING THE SURGERY TO THE SURGEON THAT A SMALL PART OF THE REAMER WAS MISSING. THE SCRUB NURSE SEARCHED FOR THE DEVICE AND COULD NOT FIND IT. THE SURGEON STATED THAT IF IT IS IN THE TIBIAL HE IS NOT PREPARED TO REMOVE THE TIBIAL REVISION IMPLANT AS IT WOULD BE MORE DETRIMENTAL TO THE PATIENT. THAT THEY WOULD X-RAY POST OPERATIVELY IF NOT FOUND. SUBSEQUENT TO SURGERY A POST OP X-RAY WAS PERFORMED IN RECOVERY ROOM IDENTIFYING THAT THE INSTRUMENT IS IN THE TIBIAL SHAFT - DISTAL TO THE TIBIAL STEM AND NOT IN CONTACT AS SURROUNDED BY PALACOS R ANTIBIOTIC CEMENT. THIS HAD BEEN IDENTIFIED TO THE SCRUB AT THE START OF THE CASE, WHICH IS WHY A COUNT OF THIS ITEM COMMENCED PRIOR TO CLOSING THE SURGICAL WOUND. ALLOWING THE SURGEON TO INTERVENE IF HE DEEMED APPROPRIATE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20692307 ↗