SIGMA LCS COMPLETE POROCOAT 1294-32-130Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295025696), received between Oct 11, 2017 and Dec 4, 2025 — classified as 15 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION OF LCS DUE TO BEARING WEARING OUT PARTICULARLY ON THE MEDIAL SIDE. THIS HAS BEEN IMPLANTED INSITU FOR A SIGNIFICANT AMOUNT OF TIME. PATIENT UNDERWENT A REVISION FROM LCS TO ATTUNE REVISION USING A STEM AND SLEEVE ON THE FEMUR & TIBIA. SURGERY WAS SUCCESSFUL AND SURGEON WAS HAPPY WITH THE BALANCE AT THE END OF THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 23720880 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTED LEFT TKR THAT REQUIRED REMOVAL OF INFECTED IMPLANTS FOR FIRST STAGE REVISION. PATIENT HAD A WASHOUT AND POLY INSERT EXCHANGE DONE.

  Patient problems: Unspecified Infection

  MAUDE report 22849875 ↗
• InjurySep 23, 2024Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS HAD A KNEE REPLACEMENT- ON- (B)(6) 2021. STARTED HAVING ISSUES UNABLE TO DO PHYSICAL THERAPY DUE TO EXTREME PAIN. WENT 9 MONTHS UNTIL HE HAD AN ADDITIONAL SURGERY. . HE HAD TO HAVE A SECOND SURGERY ON THIS SAME KNEE AND TOLD HIM THAT A PIECE FELL APART. HE WANTS TO LET SOMEONE KNOW THAT HIS FIRST KNEE REPLACEMENT WAS A FAILURE. ADDITIONAL INFORMATION RECEIVED DATED SEP 16, 2024: ON (B)(6) 2021, THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY. THE PATIENT WAS REVISED ON (B)(6) 2023 TO ADDRESS PAIN AND LIMITED MOBILITY AS WELL AS POSSIBLE INFECTION. PATIENT STATED THAT ONE OF THE PIECES "BROKE OFF", BUT WAS NOT CERTAIN WHICH PIECE BROKE. DEPUY COMPONENTS WERE REMOVED AND DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. DOI: (B)(6) 2021. DOR: (B)(6) 2023. RIGHT KNEE.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Joint Contracture; Loss of Range of Motion; Pain; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20279528 ↗
• InjuryJan 29, 2023Osseointegration Problem; Osseointegration Problem

  THE AFFECTED SIDE INVOLVED IN THIS EVENT WAS THE LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16261818 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  QUERY INFECTION. THE SURGEON DECIDED TO CHANGE THE INSERT AND RESURFACE PATELLA. THE PATELLA WAS NOT ORIGINALLY DONE IN THE 1ST SURGERY IN 2017. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? YES, IF YES, PLEASE DESCRIBE. QUERY INFECTION, DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? UNKNOWN, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES , WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY? NO, IP-(B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: Foreign Body Reaction; Unspecified Infection

  MAUDE report 16131444 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CR150/MBT TRAY IN SITU. ORIGINAL SURGERY 2015 BY DR. INSTABILITY AND X-RAY SHOWS OVERHANGING TIBIAL TRAY AND INTERNALLY ROTATED FEMUR. MCL INSUFFICIENT. SOME WEAR NOTED ON IMPLANTS. REVISED TO ATTUNE REVISION. DOI: 2015, DOR: UNKNOWN, UNKNOWN SIDE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 15979219 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE TOTAL KNEE ARTHROPLASTY WITH THE MBT AND THE LCS FOR THE LEFT KNEE JOINT AT ANOTHER HOSPITAL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT WAS INFECTED WITH PSEUDOMONAS AERUGINOSA. THE IMPLANTS WILL NOT BE RETURNED BECAUSE THE PATIENT WAS INFECTED. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15199273 ↗
• InjuryJul 5, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. AFTER SURGERY, INFECTION OCCURRED. SINCE THE INFECTION HAS LOOSENED BOTH THE FEMUR AND TIBIA, THE SURGEON INTENDS TO PERFORM A REVISION IN 2 STAGES. ON (B)(6) 2022, THE 1ST REVISION SURGERY WAS PERFORMED SUCCESSFULLY. THE IMPLANTS USED IN THE INITIAL SURGERY WERE REMOVED, AND A MOLD WAS NEWLY USED FOR THE TREATMENT. ON (B)(6) 2022, THE 2ND REVISION SURGERY WILL BE PERFORMED WITH ATTUNE IMPLANTS. DOI: (B)(6) 2016. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 14914134 ↗
• MalfunctionNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6); STUDY:DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR PAIN: MIGRATION/LOOSENING - TIBIAL EVENT IS SERIOUS, AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE, AND THERE IS A REMOTE POSSIBILITY THAT THE EVENT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018; DATE OF EVENT (ONSET): (B)(6) 2020; (LEFT KNEE). TREATMENT: AWAITING REVISION OF TIBIAL TRAY.

  Patient problems: Joint Laxity; Pain

  MAUDE report 10898233 ↗
• InjuryJul 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT UNDERWENT A PRIMARY LEFT KNEE REVISION WITH NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2020, THE PATIENT PRESENTED FOR A LEFT KNEE EVALUATION DUE TO ADHESIONS/ARTHROFIBROSIS, SLIGHT INSTABILITY, DECREASED RANGE OF MOTION, AND NON-PROGRESSING PHYSICAL THERAPY. ON (B)(6) 2020, THE PHYSICIAN NOTED THE PATIENT WAS CONTINUING PHYSICAL THERAPY WITH IMPROVING RANGE OF MOTION. ON (B)(6) 2020, THE PATIENT UNDERWENT A LEFT KNEE CLOSED MANIPULATION UNDER ANESTHESIA DUE TO ADHESIONS/ARTHROFIBROSIS AND STIFFNESS. THE PROCEDURE WAS COMPLETED WITHOUT APPARENT INTRA-OPERATIVE COMPLICATIONS. NO PRODUCTS WERE REVISED.

  Patient problems: Adhesion(s); Limited Mobility Of The Implanted Joint; Muscular Rigidity; No Code Available

  MAUDE report 10352211 ↗
• InjuryMay 21, 2020Migration; Migration

  REVISION OF LCS COMPONENTS DUE TO INSTABILITY AND SUBSIDENCE.

  Patient problems: No Code Available

  MAUDE report 10080238 ↗
• InjuryApr 13, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT HAS NOT BEEN HAPPY WITH KNEE SINCE IT WAS IMPLANTED AND COMPLAINING OF PAIN. SURGEON HAD SCANS OF THE KNEE DONE, AND SOME HOT SPOTS SHOWED UP AROUND THE KNEE. SURGEON THOUGHT MAYBE THE IMPLANT WAS LOOSE. WHEN REMOVING THE IMPLANT, THE SURGEON STATED THE IMPLANT WAS NOT LOOSE BUT STILL REMOVED DUE TO PATIENTS REQUEST.

  Patient problems: No Code Available; Pain

  MAUDE report 9954216 ↗
• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR - DVT: CLOTS IN PERONEAL VESSELS, AS WELL AS THE POSTERIOR TIBIAL. EVENT IS SERIOUS AND IS CONSIDERED MODERATE, EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT: (B)(6) 2019, (RIGHT KNEE).

  Patient problems: Thrombosis

  MAUDE report 9008611 ↗
• InjuryFeb 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WENT TO THE DOCTOR DUE TO TIBIAL PAIN. THE SURGEON CONVERTED TO A TC3 FEM AND REVISION MBT TIBIA. HE KEPT THE ORIGINAL PATELLA IMPLANTED. DOI: (B)(6) 2017. DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8366609 ↗
• MalfunctionJan 30, 2018Device Disinfection Or Sterilization Issue; Device Disinfection Or Sterilization Issue

  CUSTOMER WROTE: "I DID A MICROBIOLOGICAL CHECK-UP ON AN IMPLANT ON (B)(6) 2017 AT 07:30. THE EXAMINATION WAS CARRIED OUT BY FIRST OPENING THE BOX, THEN HAND DISINFECTING OF THE STAFF´S HAND AND THEN TAKING THE SAMPLE. THE RESULT SHOCKS ME, AS THE SAMPLING AEROBIC SPORE FORMERS SHOWS TURF GROWTH 16 - 50 CFU. AS YOU CAN READ IN THE LITERATURE, A DISINFECTION OF THE OUTER PACKAGING IS WITHOUT EFFECT." CUSTOMER IS ASKING FOR A STATEMENT. CUSTOMER DOES NOT REMEMBER REF/LOT; A LIST OF POSSIBLE SAMPLES IS ATTACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7227486 ↗
• InjuryOct 25, 2017Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT DUE TO A FALL. LOOSENING OCCURRED AT THE BONE TO IMPLANT INTERFACE.

  Patient problems: No Information

  MAUDE report 6978606 ↗
• InjuryOct 11, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DER STATES THAT THE PATIENT COMPLAINS OF PAIN ON LATERAL ASPECT OF TIBIA. XRAYS SHOWED TIBIA TRAY OVERHANGING. TRAY AND INSERT REMOVE AND REPLACE WITH A THICKER INSERT AND SMALLER TRAY.

  Patient problems: Pain

  MAUDE report 6939709 ↗