P.F.C. SIGMA 96-0703Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295233640), received between Oct 11, 2019 and Oct 29, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 reports).

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.

• InjuryOct 29, 2020Loss of Osseointegration; Loss of Osseointegration

  REVISION ON (B)(6) 2020 OF PREVIOUSLY REVISED KNEE TO TREAT BONE LOSS SECONDARY TO ASEPTIC FEMORAL IMPLANT LOOSENING. AN ATTUNE REVISION WAS USED TO REVISE A TC3. ORIGINAL REVISION SURGERY (TC3) WAS CONDUCTED ON (B)(6) 2009. REASON FOR RE-REVISION WAS FEMORAL LOOSENING (FEMUR + STEM CONSTRUCT). THE ORIGINAL MBT REVISION WAS STILL WELL FIXED SO DIDN'T REQUIRE REMOVAL/REPLACEMENT. TC3 FEMUR + STEM WAS REMOVED. INSERT WAS REMOVED. ATTUNE REVISION FEMUR, SLEEVE AND STEM IMPLANTED. ATTUNE REVISION CRS INSERT IMPLANTED INTO ORIGINAL MBT TRAY (NOT INDICATED).

  Patient problems: Inadequate Osseointegration; Injury; No Code Available

  MAUDE report 10758068 ↗
• InjuryDec 11, 2019Loss of or Failure to Bond; Break; Loss of Osseointegration; Osseointegration Problem; Loss of or Failure to Bond; Break; Loss of Osseointegration; Osseointegration Problem

  IT WAS REPORTED THAT STEM FRAGMENT WAS REMOVED LAST (B)(6) 2019. DOI: (B)(6) 2012 (FEMORAL STEM). (B)(6) 2019 (FEMORAL). DOR: (B)(6) 2019.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9452552 ↗
• InjuryOct 11, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REPORTING A REVISION OF SIGMA TC3 FIXED BEARING KNEE IMPLANTS AT ROYAL LANCASTER INFIRMARY. ALL COMPONENTS WERE REMOVED WITHOUT DIFFICULTY. IT SHOULD BE NOTED THAT UPON REMOVAL OF THE FEMORAL COMPONENT, IT WAS OBSERVED THAT THE FEMORAL COMPONENT AND THE FEMORAL ADAPTOR WERE SLIGHTLY LOOSE AND CAN BE ROTATED ¿ QUESTIONING WHETHER INSUFFICIENT TORQUE WAS USED UPON INITIAL IMPLANT PREPARATION BY SURGICAL TEAM. THE DISASSOCIATION OCCURRED BETWEEN THE BOLT AND THE STEM AS THIS IS A STEM-BOLT CONFIGURATION.

  Patient problems: No Code Available; Pain

  MAUDE report 9180949 ↗