SIGMA LCS COMPLETE POROCOAT 1294-34-130Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295025870), received between Aug 18, 2017 and Sep 26, 2024 — classified as 11 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A REVISION DONE FOR FLEXION INSTABILITY. UNFORTUNATELY NO IMPLANT RECORD WAS AVAILABLE. SOME OF THE IMPLANTS HAD LEGIBLE IMPLANT, BUT OTHERS WERE NOT. THE METAL BACKED PATELLA WAS REPLACED WITH A NEW POLY. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20312065 ↗
• InjuryApr 22, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED FOR AESEPTIC LOOSENING OF THE NON-CEMENTED TIBIAL COMPONENT. IT DID NOT COME OUT EASY. THERE WAS MOSTLY FIBROUS INGROWTH IN THE POROUS COATED SIGMA IMPLANTS. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14186602 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY OPERATIVE NOTES (B)(6) 2009 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. OFFICE NOTES (B)(6) 2021 INDICATE THE PATIENT IS EXPERIENCING PAIN AND SWELLING OF THE RIGHT KNEE IN ADDITION TO THE PREVIOUSLY NOTED AE. NO ADDITIONAL TREATMENT PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Swelling/ Edema

  MAUDE report 12908030 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12780007 ↗
• InjuryApr 7, 2021Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO PAIN AND LOOSENING OF THE TIBIAL TRAY AT THE IMPLANT TO BONE INTERFACE. PATIENT HAD A RIGHT KNEE REPLACEMENT WITH A DIFFERENT SURGEON IN 2019, WITH SIGMA CRUCIATE RETAINING POROUS COATED TIBIAL AND FEMORAL COMPONENTS. PATIENT REPORTED HAVING PAIN AS EARLY AS THREE MONTHS AFTER SURGERY, INCREASING TO THE POINT THAT PATIENT VISITED THE SURGEON FOR A SOLUTION. SURGEON SUGGESTED A REVISION TO CEMENTED COMPONENTS. THE FEMORAL COMPONENTS WAS WELL FIXED, THE TIBIAL COMPONENT LESS SO BUT DID NOT APPEAR GROSSLY LOOSE. THE RP CURVED INSERT SHOWED NO WEAR ON GROSS EXAMINATION. SURGEON RE-IMPLANTED A PRIMARY ATTUNE PS FEMORAL COMPONENT, WITH A STATEMENT REVISION TIBIAL TRAY AND A 14 MM PS FIXED BEARING INSERT. SURGEON WENT WELL, WITH A SATISFACTORY OUTCOME. DOI: (B)(6) 2019 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 11628833 ↗
• InjuryMay 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10102698 ↗
• InjuryDec 4, 2019Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. FAILURE OF INGROWTH IN THE TIBIAL COMPONENT. NO ADDITIONAL INFORMATION. DOI: UNKNOWN; DOR: (B)(6) 2019 LEFT KNEE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9412636 ↗
• InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9324142 ↗
• InjuryAug 8, 2018Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL AND TIBIAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. REVISED TO TC3 AND PATELLA WAS WELL FIXED AND REMAINED IMPLANTED. DOI: (B)(6) 2010; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7761706 ↗
• InjuryAug 28, 2017Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS PAIN. IT WAS ALSO REPORTED THAT THE CEMENTLESS TIBIAL TRAY APPEARED TO BE LOOSE AT UNKNOWN INTERFACE.

  Patient problems: Pain

  MAUDE report 6824707 ↗
• InjuryAug 18, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN AND STIFFNESS.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 6805198 ↗