SIGMA 1960-50-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295075110), received between Sep 7, 2017 and Feb 3, 2026 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INSTABILITY OF PREVIOUS IMPLANTS. REMOVED OLD IMPLANTS AND REVISED WITH NEW. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24245692 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. POSTERIOR LATER WEAR ON INSERT. UNKNOWN LOT NUMBERS. SURGEON REMOVED FEMUR, TIBIA, INSERT.

  Patient problems: Joint Laxity

  MAUDE report 23756280 ↗
• InjuryDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANTS REMOVED DUE TO INSTABILITY AND ANTERIOR KNEE PAIN. SURGEON BELIEVES THE JOINT LINE WAS RAISED TOO MUCH RESULTING IN PATELLA BAJA. THERE WAS NO SURGICAL DELAY.

  Patient problems: Joint Laxity; Pain

  MAUDE report 15939128 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED TO ADDRESS PAIN DUE TO OVERSTUFFED TIBIAL IMPLANT. ISSUE WAS WITH THE SIZING OF THE IMPLANT. NO LOOSENING WAS PRESENT.

  Patient problems: Pain

  MAUDE report 14196703 ↗
• InjuryMar 1, 2022Loss of or Failure to Bond; Fracture; Use of Device Problem; Loss of or Failure to Bond; Fracture; Use of Device Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, 2003, THE PATIENT UNDERWENT THE TKA SURGERY WITH THE P.F.C SIGUMA FEMORAL COMPONENT IN QUESTION. AFTER THE SURGERY, IT WAS CONFIRMED THAT THE MEDIAL CONDYLE OF FEMORAL COMPONENT WAS CRUSHED AND MISALIGNED ON AN UNKNOWN DATE. THE REVISION SURGERY IS PLANED ON (B)(6) 2022. NO FURTHER INFORMATION IS AVAILABLE. AS OF THIS REPORT, THERE HAS BEEN NO RECORD OF REVISION.

  Patient problems: Insufficient Information

  MAUDE report 13632882 ↗
• InjuryApr 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. NO LOOSENING REPORTED. NO DELAY TO SURGERY. DOI: (B)(6) 2014, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11699626 ↗
• InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FLEXION INSTABILITY WITH HER PREVIOUS KNEE REPLACEMENT. SURGEON TIGHTENED HER FLEXION GAP WITH A TC3 FEMUR, +2 BOLT AND TC3 RP INSERT. DOI: (B)(6) 2015 DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10461207 ↗
• InjuryMar 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REASON FOR REVISION WAS INSTABILITY. THE MEDIAL FEMORAL CONDYLE WAS FRACTURED AT ONE POINT. IT WAS HEALED AT TIME OF REVISION.

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

  MAUDE report 9785517 ↗
• MalfunctionDec 2, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  ON SUNDAY THE 13TH IN THE SURGERY PROCESS THE J&J INHOUSE INSTRUMENTALIST DETECTED THAT THE PRODUCT SIGMA PS FEMUR SZ2 R (CODE 196050200 AND LOT: 8014599), HAD THE PLASTIC PROTECTOR OPEN. AFTER SURGICAL PROCEDURE HAS ADVANCED 10 MINUTES AND BEFORE PLACING THE DEFINITIVE PROSTHESIS ASKS THE CIRCULATOR TO PASS THE PROSTHESES AND THEY REALIZE THAT WHEN THEY OPENED THE BOX OF THE FEMORAL COMPONENT THEY WERE OPEN AND THEREFORE WERE NOT STERILE, THIS CAUSED DISCOMFORT WITH THE SURGEON. SO IMMEDIATELY NOTIFY THE J&J EXECUTIVE TO URGENTLY MANAGE YOUR REPLACEMENT. THIS CLAIM WAS ACCEPTED BY THE DELIVER TEAM AS A DISTRIBUTION CLAIM. THIS DELAY IN REPLACING THE PRODUCT IN THE INSTITUTION CAUSED THE PATIENT TO BE EXPOSED AT AN ADDITIONAL TIME TO THE ANESTHESIA OF THE PLANNED.   DATE OF AWARENESS OF ADVERSE INCIDENT: NOVEMBER 5.

  Patient problems: Not Applicable

  MAUDE report 9398288 ↗
• MalfunctionJul 17, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  CUSTOMER SENT IMPLANT TO DOT TO HAVE IT COATED WITH TINI. AT INCOMING INSPECTION DOT IDENTIFIED SOME SCRATCHES ON THE IMPLANT AND REFUSED IT TO UNDERGO THE TINI COATING-PROCESS. NO SURGERY DELAY, NO ADVERSE CONSEQUENCES FOR PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8799297 ↗
• InjurySep 26, 2017Malposition of Device; Malposition of Device

  IT WAS INDICATED THAT FEMORAL COMPONENT WAS IMPLANTED IN EXCESSIVE VALGUS DUE TO A CORTICAL PERFORATION WITH THE IM T-HANDLE.

  Patient problems: No Information

  MAUDE report 6893492 ↗
• InjurySep 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 6847815 ↗