P.F.C. SIGMA 96-0846Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295234203), received between May 13, 2019 and Jun 29, 2021 — classified as 12 injuries.

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INFECTION WAS CONFIRMED. AS THIS WAS A REVISION PROCEDURE, THERE WAS NO SURGICAL DELAY. THE PRODUCT SPECIALIST THINKS IT WAS A COMPETITORS CEMENT THAT WAS USED. ALL KNEE COMPONENTS WERE REMOVED, AND A TEMPORARY CEMENT SPACER WAS INSERTED.

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

  MAUDE report 12089649 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INFECTION WAS CONFIRMED. AS THIS WAS A REVISION PROCEDURE, THERE WAS NO SURGICAL DELAY. THE PRODUCT SPECIALIST THINKS IT WAS A COMPETITORS CEMENT THAT WAS USED. ALL KNEE COMPONENTS WERE REMOVED, AND A TEMPORARY CEMENT SPACER WAS INSERTED.

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

  MAUDE report 12089643 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. THE DOCTOR DECIDE TO REMOVE ALL COMPONENTS DO TO THIS INFECTION. IT WAS ALSO REPORTED THAT A FEMORAL IMPACTOR TIP BROKE OFF DURING THIS SURGERY. A COMPETITOR CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2021 RIGHT KNEE.

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

  MAUDE report 11754173 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. THE DOCTOR DECIDE TO REMOVE ALL COMPONENTS DO TO THIS INFECTION. IT WAS ALSO REPORTED THAT A FEMORAL IMPACTOR TIP BROKE OFF DURING THIS SURGERY. A COMPETITOR CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2021 DOR: (B)(6) 2021 RIGHT KNEE.

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

  MAUDE report 11754165 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL RIGHT KNEE. NO ADDITIONAL INFORMATION. NO SURGICAL DELAY. DOI: (B)(6) 2014; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11517136 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION OF THE LEFT KNEE. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2021; LEFT KNEE.

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

  MAUDE report 11399867 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. UNKNOWN BONE CEMENT WAS USED. NO SURGICAL DELAY. DOI: NOT INDICATED/UNKNOWN, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11142670 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RADIOLOGY REPORT (B)(6) 2017 (POST REVISION SURGERY) REVEALS THE HARDWARE APPEARS TO BE INTACT. THERE IS A REMOTE AVULSION FRACTURE OF THE MEDIAL ASPECT OF THE MEDIAL FEMORAL CONDYLE. THERE IS NO INDICATION OF TREATMENT RELATED TO THIS AVULSION FRACTURE. IT IS UNKNOWN WHEN THIS FRACTURE OCCURRED, DURING THE REMOVAL OF PREVIOUS IMPLANTS OR IMPLANTATION OF REVISION IMPLANTS. THEREFORE, THIS WILL NOT BE CAPTURED AS A SEPARATE EVENT. OFFICE NOTES OCT 2017 ¿ MAR 2020 INDICATE THE PATIENT CONTINUES TO EXPERIENCE PAIN, STIFFNESS, WEAKNESS, INSTABILITY, SWELLING AND LEG LENGTH DISCREPANCY. THE PATIENT ALSO STATES SHE HAS SKIN DISCOLORATION ON THE MEDIAL ASPECT OF HER LOWER LEG. IT IS INDICATED THE SURGEON HAS DISCUSSED THE POTENTIAL NEED FOR FUTURE REVISION, HOWEVER, THERE IS NO INDICATION AN ADDITIONAL REVISION SURGERY HAS TAKEN PLACE. IT IS INDICATED, HOWEVER, THAT THE PATIENT HAS RECEIVED PAIN BLOCK INJECTIONS DUE TO HER KNEE PAIN. A SHOE HEEL LIFT WAS PROVIDED TO HELP ADDRESS THE LEG LENGTH DISCREPANCY. WHOLE BODY BONE SCAN WAS PERFORMED ON (B)(6) 2019 REVEALS LOW-LEVEL ACTIVITY DIFFUSELY AROUND THE LEFT KNEE PROSTHETIC. NO SIGN OF OSTEOMYELITIS OR FRACTURE. DOI: (B)(6) 2016 (PATELLA).

  Patient problems: Fatigue; Joint Laxity; Muscular Rigidity; Pain; Physical Asymmetry; Skin Discoloration; Swelling/ Edema

  MAUDE report 10927397 ↗
• InjuryMar 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9832627 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BROKE HER DISTAL FEMUR DUE TO FALL. A DISTAL FEMUR WITH SLEEVE AND STEM WAS USED TO GAIN STABILITY. ORIGINAL IMPLANT DATE WAS UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9701634 ↗
• InjuryMay 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO SOME ISOLATED FEMORAL PAIN. DOI: 1-2 YEARS AGO; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8605441 ↗
• InjuryMay 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO SOME ISOLATED FEMORAL PAIN. DOI: 1-2 YEARS AGO. DOR: (B)(6) 2019. LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8605438 ↗