SIGMA 1024-53-310Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295002567), received between Jan 20, 2020 and Sep 26, 2022 — classified as 2 injuries, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY LM UNICOMPARTMENTAL KNEE SURGERY ON (B)(6) 2020 WHEN A SIGMA PARTIAL KNEE WAS UTILIZED (DR (B)(6), (B)(6) PRIVATE). PATIENT PRESENTED WITH A PAINFUL KNEE AND THE TIBIAL COMPONENT WAS REVISED ON (B)(6) 2021 (DR (B)(6), (B)(6) HOSPITAL) (SEE (B)(4)). PATIENT INITIALLY DID WELL AND PRESENTED AGAIN WITH A PAINFUL KNEE - THIS RESULTED ON A POLY EXCHANGE OF THE TIBIAL COMPONENT AND A WASHOUT ON (B)(6) 2021 (DR (B)(6), (B)(6) (SEE (B)(4)). PATIENT WAS THEN DOING WELL UNTIL APPROXIMATELY 6 MONTHS AGO WHEN HE STARTED TO EXPERIENCE A PAINFUL KNEE. A DECISION WAS MADE TO REVISE THE SIGMA PARTIAL TO A TOTAL KNEE WITH A STEM AND SLEEVED TIBIA. ON OPENING THE KNEE ((B)(6) 2022, DR (B)(6), (B)(6) HOSPITAL) THE TIBIAL COMPONENT WAS FOUND TO BE LOOSE - WITH THE FAILURE AT THE BONE CEMENT/ BONE INTERFACE. ALL COMPONENTS WERE REMOVED AND STEMMED AND SLEEVED ATTUNE REVISION TIBIAL COMPONENT IMPLANTED ALONG WITH A PRIMARY PS FEMORAL COMPONENT. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? UNKNOWN, IF YES, PLEASE DESCRIBE. LOOSE TIBIAL COMPONENT - REVISION TO TOTAL KNEE , DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OST

  Patient problems: Pain; Unspecified Infection

  MAUDE report 15484618 ↗
• InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY UNICOMPARTMENTAL LEFT MEDIAL KNEE REPLACEMENT ON (B)(6) 2020 (B)(6) HOSPITAL. PATIENT RETURNED FOR A REVISION OF THE TIBIAL COMPONENT ON (B)(6) 2021 (B)(6) HOSPITAL. SEE (B)(4) AT THIS STAGE THE TIBIAL COMPONENT WAS LOOSE. THE BONE WAS PREPARED AND ANOTHER TIBIAL COMPONENT AND INSERT WERE IMPLANTED. PATIENT HAS BEEN DOING VERY WELL AND REPORTED WAKING UP ON SUNDAY (B)(6) 2021 WITH A PAINFUL KNEE. THE KNEE HAS BECOME INCREASINGLY PAINFUL OVER THE NEXT 24 HOURS AND THE PATIENT HAS NOW PRESENTED TO (B)(6) HOSPITAL. A DECISION WAS MADE TO OPEN THE KNEE AS INFECTION WAS SUSPECTED. ON OPENING THE KNEE (B)(6) HOSPITAL (B)(6) 2021. THE JOINT WAS FULL OF PUSS. THE KNEE WAS WASHED OUT SEVERAL TIMES WITH A RANGE OF SOLUTIONS. THE TIBIAL BEARING WAS REMOVED AND A NEW BEARING INSERTED. INFECTION REQUIRING WASHOUT AND EXCHANGE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 12496821 ↗
• 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 9607958 ↗