SIGMA 1960-40-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295075011), received between Nov 3, 2017 and Mar 28, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Incorrect Device Or Component Shipped” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE LITIGATION COMPLAINT RECEIVED AD 12 MAR 2024 WAS REVIEWED BY THE CLINICIAN. ON (B)(6) 2014, THE PATIENT HAD A BILATERAL CEMENTED TOTAL KNEE ARTHROPLASTY TO ADDRESS, BILATERAL KNEE PAIN AND BILATERAL KNEE OSTEOARTHRITIS END-STAGE. ALL COMPONENTS IMPLANTED WERE DEPUY PRODUCTS, INCLUDING THE CEMENT AND PATELLA. ON (B)(6) 2021, THE PATIENT WAS REVISED DUE TO LEFT TOTAL KNEE ARTHROPLASTY, TO ADDRESS THE GROSS FAILURE OF THE TIBIAL TRAY WITH A WELL FIXED FEMORAL AND PATELLA COMPONENT. PRIOR TO SURGERY, THE PATIENT EXPERIENCED PAIN, INSTABILITY, AND DIFFICULTY AMBULATING. DURING THE PROCEDURE, THE SURGEON OBSERVED THAT THE TIBIAL TRAY WAS GROSSLY LOOSE AND HAD COLLAPSED CAUSING SIGNIFICANT BONE LOSS ON THE ANTERIOR AND LATERAL ASPECT OF THE TIBIA. DURING THE PROCEDURE, THE SURGEON REPORTED THAT DURING IMPACTION A BONE FRACTURE ALONG THE LATERAL TIBIAL CORTEX WAS NOTED. THE TIBIAL TRAY, INSERT, AND FEMORAL COMPONENT WERE REVISED. DOI: (B)(6) 2014. DOR: (B)(6), 2021. LEFT KNEE.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain

  MAUDE report 18995419 ↗
• InjuryNov 3, 2017Incorrect Device Or Component Shipped; Manufacturing, Packaging or Shipping Problem; Incorrect Device Or Component Shipped; Manufacturing, Packaging or Shipping Problem

  COMPLAINT DESCRIPTION: IT WAS REPORTED THAT UPON OPENING THE BOX INSIDE WAS A 2 LEFT FEMUR IMPLANT BUT SUPPOSED TO BE A 1.5LEFT FEMUR IMPLANT (OF PFC SIGMA). / / INVESTIGATION METHOD: / / INVESTIGATION SUMMARY:

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 7000183 ↗