SIGMA 1024-53-311Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295002574), received between Nov 17, 2017 and Jan 20, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• MalfunctionJan 20, 2020Difficult to Insert; Device-Device Incompatibility; Difficult to Insert; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A UNICOMPARTMENTAL KNEE REPLACEMENT ON THE LEFT MEDIAL COMPARTMENT ON THE PATIENT. NORMAL PROTOCOL WAS TAKEN AS FAR AS INSTRUMENTS AND IMPLANTS AT THE HOSPITAL PRIOR TO THE CASE. FIRST ISSUE WAS WITH THE "ANTERIOR CHISEL" THROUGH THE ANTERIOR CHAMFER OF THE SIZE 2 CUTTING BLOCK. THE CHISEL (202485000 LOT PG0608) SPLIT IN HALF INSIDE THE CUTTING BLOCK. THE BLOCK WAS REMOVED FROM THE DISTAL FEMUR, THE BROKEN CHISEL WAS THEN REMOVED FROM THE CUTTING BLOCK. THE CUTTING BLOCK WAS PLACED BACK ON THE DISTAL FEMUR AND THE LUG DRILL WAS ALLOWED TO PASS THROUGH THE ANTERIOR CHAMFER. THIS PROBLEM DID EXTEND THE TIME OF THE OPERATION. THE REST OF THE OPERATION WENT SMOOTHLY UNTIL INSERTION OF THE FINAL POLY IMPLANT. THE SURGEON HAS A VERY DETAILED AND THOROUGH DEBRIDEMENT OF THE IMPLANTS BEFORE HE PLACES HIS FINAL INSERT COMPONENT ON ALL OF HIS TOTAL AND UNICOMPARTMENT KNEES. THERE WAS NO CEMENT ON THE TRAY, NO SOFT TISSUE POSTERIOR AND THERE WAS NO SOFT TISSUE COVERING THE TIBIAL COMPONENT TO PREVENT INSERTION OF THE POLY IN TO THE TIBIAL COMPONENT. THE DESIRED POLY THICKNESS WAS OPENED AND MATCHED THE IMPLANTED LM SIZE 3 TIBIAL COMPONENT. THE I

  Patient problems: Not Applicable

  MAUDE report 9607962 ↗
• InjuryNov 17, 2017Misconnection; Misconnection

  SYNERGY FORM STATES THAT UNICOMPARTMENTAL KNEE REPLACEMENT WAS PERFORMED. ON INSERTION OF THE TIBIAL INSERT IT WAS NOTED THAT THE LOCKING MECHANISM DID NOT LOCK THE LINER. SURGEON IMPACTED LINER BUT LINER DID NOT LOCK. THE LINER WAS THEN REMOVED AND A SIZE 3, 10 MM LINER WAS THEN IMPLANTED AND THE LOCKING MECHANISM WORKED. SURGEON HAS QUESTIONED THE LOCKING MECHANISM AND WOULD LIKE IT TO BE CHECKED.

  Patient problems: No Information

  MAUDE report 7040774 ↗