NA 86-7410Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295217800), received between Mar 22, 2018 and Sep 20, 2023 — classified as 10 injuries.

The most frequently reported specific device problem is “Fracture” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS IDENTIFIED THAT ON (B)(6) 2023, THERE WAS A REPORT FOR ASEPTIC LOOSENING LEFT REVISION (KNEE HAS BEEN REVISED IN THE PAST). DOI: (B)(6) 2013. DOR: UNKNOWN. LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17781303 ↗
• InjuryJul 7, 2021Fracture; Fracture

  PATIENT UNDERWENT A COMPLEX PRIMARY TKR ON THE (B)(6) 2019 FOLLOWING A MOTOR VEHICLE ACCIDENT - SHE RECEIVED A LPS DISTAL FEMORAL REPLACEMENT WITH MBT REVISION TIBIA. SHE HAD A FALL A WEEK AGO AND SUSTAINED A PERIPROSTHETIC FRACTURE OF THE FEMUR AND REQUIRED REVISION SURGERY. THE TIBIAL COMPONENTS FROM THE PRIMARY SURGERY WERE WELL FIXED AND LEFT IN PLACE, THE FEMORAL COMPONENTS WERE REMOVED AND REPLACED WITH NEW COMPONENTS. THERE WAS A FRACTURE OF THE PRESS FIT STEM AT THE JUNCTION OF THE STEM/SLEEVE AS A RESULT OF THE FALL. THE RETRIEVED COMPONENTS WERE SENT TO THE BIO ENGINEERING DEPARTMENT AT ROYAL PERTH HOSPITAL FOR EVALUATION AS PER STANDARD RETRIEVAL POLICY HERE IN WA (NOT AVAILABLE FOR RETURN). THERE WERE NO FRAGMENTS GENERATED AS A RESULT OF THE BREAKAGE AND ALL PARTS WERE RETRIEVED.

  Patient problems: Fall; Limb Fracture; Pain

  MAUDE report 12131416 ↗
• InjuryFeb 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AT THE END OF STEM AND IN THE TIBIA. REMOVED POLY TRAY AND STEM. IMPLANTED SHORT CEMENTED STEM, NEW TRAY AND POLY. DOI: (B)(6) 2018. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11311402 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL KNEE TO ADDRESS INSTABILITY AND TIBIAL IMPLANT MIGRATION/LOOSENING. DATE OF IMPLANTATION: (B)(6) 2013, DATE OF REVISION: (B)(6) 2020, (RIGHT KNEE). TREATMENT: REVISION OF THE TIBIAL CONSTRUCT AND INSERT.

  Patient problems: Joint Laxity

  MAUDE report 10928297 ↗
• InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY ISSUES. A REVISION KNEE WAS REPLACED. ORIGINAL IMPLANT DATE AND LOT NUMBERS ON IMPLANTS THAT WERE REMOVED ARE UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10852043 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO PAIN, INSTABILITY, EFFUSION, ADHESIONS, AND SYNOVITIS. ALL PRODUCTS WERE REVISED TO COMPETITOR COMPONENTS. DOI: UNKNOWN, DOR: (B)(6) 2019.

  Patient problems: Adhesion(s); Edema; No Code Available; Pain

  MAUDE report 9495195 ↗
• InjuryJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMMUNICATION RECEIVED. AS VERBALIZED,"I HAVE A DEPUY TC KNEE REVISION SYSTEM- PFC SIGMA KNEE REPLACEMENT. I HAVE LIMITED RANGE OF MOTION, THE PAIN GOES DOWN TO THE FEMUR PART OF THE LEG DOWN TO MY ANKLE. I'M HAVING PROBLEMS OF THIS APART FROM BEING NOT STABLE". UPDATE 23-MAY-2018: PATIENT CONFIRMED THE ABOVE SYMPTOMS OF PAIN, SWELLING, AND DECREASED ROM. MEDICAL RECORDS REPORT PAIN, AND INDICATE THAT PATIENT HAS HAD A KNEE REVISION ON AN UNKNOWN DATE. DOI: (B)(6) 2013; DOR: UNKNOWN; (LEFT KNEE).

  Patient problems: Fatigue; Loss of Range of Motion; Nerve Damage; No Code Available; Pain; Physical Asymmetry; Swelling; Swelling/ Edema; Weakness

  MAUDE report 8239309 ↗
• InjuryJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMMUNICATION RECEIVED. AS VERBALIZED,"I HAVE A DEPUY TC KNEE REVISION SYSTEM- PFC SIGMA KNEE REPLACEMENT. I HAVE LIMITED RANGE OF MOTION, THE PAIN GOES DOWN TO THE FEMUR PART OF THE LEG DOWN TO MY ANKLE. I'M HAVING PROBLEMS OF THIS APART FROM BEING NOT STABLE". UPDATE 23-MAY-2018: PATIENT CONFIRMED THE ABOVE SYMPTOMS OF PAIN, SWELLING, AND DECREASED ROM. MEDICAL RECORDS REPORT PAIN, AND INDICATE THAT PATIENT HAS HAD A KNEE REVISION ON AN UNKNOWN DATE. DOI: (B)(6) 2013; DOR: UNKNOWN; (LEFT KNEE).

  Patient problems: Fatigue; Loss of Range of Motion; Nerve Damage; No Code Available; Pain; Physical Asymmetry; Swelling; Swelling/ Edema; Weakness

  MAUDE report 8239293 ↗
• InjuryAug 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT:(B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR ABOVE THE KNEE AMPUTATION RELATED TO WOUND DEHISCENCE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. DOE: (B)(6) 2011/ DOI: (B)(6) 2011 / DATE OF AMPUTATION: (B)(6) 2011. (RIGHT, KNEE).

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 7781141 ↗
• InjuryMar 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS TIBIAL LOOSENING AT THE UNKNOWN INTERFACE. UNKNOWN CEMENT MANUFACTURER. SURGEON REMOVED THE COMPONENTS AND NEW IMPLANTS WERE PLACE IN TIBIA. DOI: UNKNOWN DOR: (B)(6) 2018 LEFT KNEE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7361479 ↗