SIGMA 1024-07-600Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295001768), received between Jun 19, 2018 and Mar 27, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 27, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION UNI KNEE TO TOTAL KNEE: PATIENT PRESENTED WITH KNEE PAIN AND HAS NOW BEEN REVISED TO A TOTAL KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8456771 ↗
• InjuryJun 19, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PATIENT HAS PRESENTED WITH A PAINFUL JOINT. PREOPERATIVE BONE SCANS SHOW INCREASED UPTAKE AROUND THE FEMORAL COMPONENT (HOT). THIS APPEARS TO INDICATE A LOOSE FEMORAL COMPONENT. ON OPENING THE KNEE SURGEON FOUND THE MEDIAL FACET OF THE UNRESURFACED PATELLA TO SHOW EVIDENCE OF CARTILAGE WEAR DUE TO ARTICULATION ON THE LATERAL EDGE OF THE FEMORAL COMPONENT. THE FEMORAL COMPONENT WAS NOT OVERTLY LOOSE, BUT WITH GENTLE PERSUASION, THE FEMORAL COMPONENT CAME AWAY FROM THE FEMUR. IT WAS BELIEVED THAT BOTH THE "LOOSE" FEMUR AND THE PATELLA WEAR WAS THE SOURCE OF THE PAIN. THE FEMORAL COMPONENT WAS REPLACED WITH NEW ONE AND THE MEDIAL FACET OF THE PATELLA RESPECTED TO REDUCE CHANCE OF IMPINGEMENT.

  Patient problems: Not Applicable; Pain

  MAUDE report 7613740 ↗