NA 1294-53-205Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295026259), received between Nov 7, 2017 and Jul 1, 2026 — classified as 13 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED A SEVERE INFECTION. SO, ALL COMPONENTS WERE REMOVED AND AN ANTIBIOTIC NAIL WAS PUT IN. DOI: (B)(6) 2019. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25681267 ↗
• InjuryOct 14, 2024Adverse 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 CHRONIC INFECTION OF RIGHT KNEE. DOI: (B)(6) 2020. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20440008 ↗
• InjuryMay 1, 2024Adverse 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 PROGRESSIVE PAIN AND RECURRENT HEMARTHROSIS RIGHT KNEE. BONE SCAN IMPLIED COMPONENTS MAY BE LOOSE. THEY WERE NOT. DOI: (B)(6) 2019. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 19221257 ↗
• InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  J-C HEALTH CARE LTD. RECEIVED ON 9 APRIL 2024 A DEMAND LETTER DATED (B)(6) 2024 PERTAINING TO A TOTAL KNEE REPLACEMENT WITH SIGMA IMPLANT. ACCORDING TO THE DEMAND LETTER, BACK IN 2019 PATIENT UNDERWENT A LT TKR IN RUSSIA (UNKNOWN IMPLANT) AND SUFFERED FROM INFECTION. THEREAFTER PATENT UNDERWENT SEVERAL INFECTION REVISIONS (ALSO IN RUSSIA) INCLUDING REMOVAL OF TIBIAL IMPLANT AND INSERTION OF SPACER, THAT DID NOT SOLVE THE INFECTION. DURING FEBRUARY-JULY 2020 PATIENT WAS TREATED AT SHEBA MEDICAL CENTER IN ISRAEL. ON (B)(6) 2020 (B)(4) CAPTURED FOR THE 1ST REVISION) PATIENT UNDERWENT A FIRST STAGE OF LT TKR REVISION AT SHEBA MEDICAL CENTER DUE TO "INFECTION AND INFLAMMATORY REACTION DUE TO INTERNAL JOINT PROSTHESIS (LEFT)" DURING WHICH HER IMPLANTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS IMPLANTED. THEREAFTER PATIENT WAS PLACED IN PLASTER CAST/BRACE AND KNEE FIXATION AND RECEIVED A LONG TERM SYSTEMIC ANTIBIOTIC TREATMENT UNDER LABORATORY MONITORING. AFTER 6 WEEKS OF ANTIBIOTIC TREATMENT WITH VANCOMYCIN AND LABORATORY MONITORING FOR ADDITIONAL 2 MONTHS, IT WAS FOUND THAT THERE WAS NO INFLAMMATION OF THE INFECTION FOLLOWING CESSATION OF THE ANTIBIOTICS AND THE KNEE WAS "QUIET", THE SE

  Patient problems: Joint Laxity; Loss of Range of Motion; Physical Asymmetry

  MAUDE report 19173462 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PERIPROSTHETIC FRACTURE OF IMPLANTS. A NEW LPS WAS IMPLANTED. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Limb Fracture

  MAUDE report 18544010 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO KNEE PAIN AND INSTABILITY. UPON TAKING AN X-RAY, IT WAS SHOWN THAT THE NEUTRAL ADAPTER BOLT HAD BROKEN OFF AND WAS FLOATING IN THE PATIENTS KNEE. THIS MEANT THE FEMORAL COMPONENT HAD COME DISENGAGED FROM THE CEMENTED SLEEVE AND STEM CONSTRUCT. UPON OPENING THE KNEE, THE BROKEN BOLT AND FEMUR WERE TAKEN OUT EASILY. THE 5 DEGREE FEMORAL ADAPTER WAS STILL TAPER ENGAGED IN THE 20MM CEMENTED SLEEVE. THERE WAS LOOSENING REPORTED AT THE BONE/CEMENT INTERFACE. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN DOR: (B)(6), 2023 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 16683081 ↗
• MalfunctionDec 6, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE LPS METAPHYSEAL SLEEVE ADAPTOR WOULD NOT MORSE TAPER TO FEMORAL METAPHYSEAL SLEEVE. 0 ADAPTOR WOULD NOT MORSE TAPER HOWEVER THE +5 WAS MORSE TAPERED SUCCESSFULLY AND IMPLANTED. THERE WAS A SURGICAL DELAY OF TWO MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15923307 ↗
• MalfunctionJun 7, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SLEEVE WAS NOT IMPLANTED. WHEN THE SURGEON WAS ASSEMBLING THE COMPONENTS, THE SLEEVE WOULD NOT ATTACH TO THE +5 ADAPTER. THE SURGEON OPENED ANOTHER SLEEVE, SIZED UP AND THE SLEEVE WENT ON THE ADAPTER PERFECTLY. SLEEVE WAS NOT IMPLANTED INTO THE PATIENT. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14619830 ↗
• InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON REPORTED TO (B)(6): "SUDDEN INCREASE OF PAIN IN THE LEFT KNEE JOINT AFTER A FALL EVENT."

  Patient problems: Fall; Pain

  MAUDE report 13928043 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT SUFFERED A FALL AND COMPLAINED OF PAIN. X-RAY REVEALED A BONE FRACTURE AND THE ADAPTOR AND BOLT IN TC3 FEMORAL COMPONENT BROKE. SURGEON WAS UNABLE TO DETERMINE IF THE BROKEN COMPONENTS CAUSED THE FRACTURE OR IF THE FALL CAUSED THE FRACTURE. REVISION WAS COMPLETED. DOI: UNK. DOR: (B)(6) 2022. R KNEE.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Fall; Pain

  MAUDE report 13598804 ↗
• InjuryJul 22, 2021Loss of or Failure to Bond; Device Dislodged or Dislocated; Loss of or Failure to Bond; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING AT THE STEM-SLEEVE JUNCTION. THE STEM WAS SPINNING LOOSE FROM THE SLEEVE IN THE CANAL. DOI: UNKNOWN. DOR: (B)(6) 2021; RIGHT KNEE.

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

  MAUDE report 12210947 ↗
• 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 12089633 ↗
• InjuryAug 19, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE UNKNOWN COMPONENT AT THE CEMENT TO IMPLANT AND BONE TO CEMENT INTERFACE. THE SLEEVE /STEM INTERFACE BROKE. UNKNOWN CEMENT WAS USED. NO SURGICAL DELAY. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2019. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10426330 ↗
• InjuryMar 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. SURGEON REMOVED EVERYTHING. DOI: (B)(6) 2019, (B)(6) 2019 (INSERT), DOR: (B)(6) 2020.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9891510 ↗
• InjuryNov 7, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS COMPONENT LOOSENING AT UNKNOWN INTERFACE. ALSO, THE IMPLANTS WERE REMOVED AND REPLACED WITH THE LPS DISTAL FEMORAL REPLACEMENT.

  Patient problems: Inadequate Osseointegration; No Information

  MAUDE report 7007276 ↗