NA 1294-35-315Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295026020), received between Jun 28, 2017 and Aug 2, 2023 — classified as 11 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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.

• InjuryAug 2, 2023Migration; Migration

  THIS PATIENT HAD REVISION SIGMA COMPONENTS CURRENTLY IMPLANTED BUT THE TIBIAL COMPONENT HAD FALLEN INTO VARUS AND THE TIBIAL STEM WAS PROTRUDING OUT OF THE LATERAL CORTEX OF THE TIBIA. THIS PATIENT ALSO HAD STABILITY ISSUES SO SURGEON REMOVED BOTH THE TIBIAL AND FEMORAL COMPONENTS AND REPLACED THEM WITH AN ATTUNE REVISION TIBIAL TRAY, STEM, AND SLEEVE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s); Joint Laxity

  MAUDE report 17446128 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION AND LOOSENING OF THE TIBIAL TRAY AT THE BONE TO CEMENT INTERFACE AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. TWO DEPUY CEMENTS WERE USED. IMPLANTS WERE REMOVED AND INSERTION OF ANTIBIOTIC SPACER WAS PERFORMED. DOI: (B)(6)2015. DOR: (B)(6)2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14103981 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS SIGNIFICANT FLEXION CONTRACTURE BUT INSTABILITY IN FLEXION. TIBIAL COMPONENTS REMOVED ALONG WITH FEMORAL COMPONENTS AND CONVERTED TO DISTAL FEMORAL REPLACEMENT ON EXISTING FEMORAL SLEEVE AND STEM. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2018. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Joint Contracture; Joint Laxity

  MAUDE report 11554898 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. ALL IMPLANTS WERE REMOVED. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 11455792 ↗
• InjurySep 1, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION OF UNKNOWN PARTS OF S-ROM NRH-KNEE BECAUSE OF FRACTURE OF FEMORAL STEM RIGHT SIDE. DOI: UNKNOWN, DOR: (B)(6) 2020. A SURGICAL DELAY WAS NOT REPORTED.

  Patient problems: Injury; No Code Available; Pain

  MAUDE report 10478870 ↗
• InjuryMay 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN, DISTAL FEMUR FRACTURE, FLEXION INSTABILITY AND TIBIAL LOOSENING AT THE BONE TO CEMENT INTERFACE DUE TO FALL. CEMENT MANUFACTURER IS UNKNOWN. IT WAS ALSO REPORTED THAT THE PATIENT HAD A PRIOR RIGHT KNEE REVISION DONE SOMETIME WITHIN THE LAST 10 YEARS IN POWAY, CA FOR TIBIAL LOOSENING. THE SURGEON TOLD THE SALES REP THAT FROM LOOKING AT THE X-RAY HIS PLAN WAS TO NAIL THE FEMUR THRU THE SIGMA CR FEMUR. HE ALSO SAID THAT HE BELIEVES THE TIBIAL COMPONENT ALSO BECAME LOOSE AFTER THE FALL, SO HE WANTED TO REVISION THE TIBIA. HE SAID THE PATIENT NEVER COMPLAINED OF PAIN OR INSTABILITY BEFORE THE FALL, EVEN THOUGH UNDER HIS EXAM, THE PATIENT HAD A LOT OF FLEXION INSTABILITY. HE FELT LIKE HE NEEDED TO ADD THICKNESS TO THE ALREADY THICK TRAY THE PATIENT CURRENTLY HAD IN. THE SURGEON IN CALIFORNIA, DIDN'T USE A STEM WITH HIS REVISION TIBIA. THE SURGEON NAILED THE FEMUR, THEN REMOVED THE LOOSE TIBIAL COMPONENT WITH EASE. HE ENDED UP USING THE NEXT SIZE TIBIAL SLEEVE (37MM), PUTTING IN A 115X14 PRESSFIT STEM, AND WENT WITH THE 25MM THICK TRAY AND A 10MM INSERT. HE WAS HAPPY WITH THE STABILITY AND WITH HOW THE FRACTURE WAS NAILED. DOI: LAST 10 YEARS; DOR:

  Patient problems: No Code Available; Pain

  MAUDE report 10030816 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO INSTABILITY, SYNOVITIS, TIBIAL INSERT WEAR, AND TIBIAL TRAY MIGRATION AND LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN MANUFACTURER PRODUCTS WERE REVISED. DEPUY PRODUCTS WERE IMPLANTED DURING THE REVISION. IT IS NOTED, AT THE END OF THE PROCEDURE, THE SURGEON REPORTED AN INTRAOPERATIVE DISTAL FEMORAL FRACTURE EXTENDING ABOUT 10 CM PROXIMALLY. THE FRACTURE WAS TREATED WITH 4 CERCLAGE WIRES AND NOTED TO BE STABLE. ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN, INSTABILITY, SWELLING, AND INFECTION. THE TIBIAL INSERT WAS EXCHANGED AND THE SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT. ON (B)(6) 2020, 5-WEEK POST-OPERATIVE VISIT INDICATED SIGNIFICANT EFFUSION OF THE LEFT KNEE WITH MILD ERYTHEMA BUT NO OVERALL WARMTH. AFTER REVISION, THE PATIENT RECEIVED IV ANTIBIOTICS VIA A PICC LINE. THE PATIENT'S CRP WERE STILL ELEVATED COMPARED TO NORMAL, BUT WERE CONTINUING TO TREND DOWN. THIS PC CAPTURES THE EFFUSION AND IV ANTIBIOTICS ON (B)(6) 2020.

  Patient problems: Edema; Erythema

  MAUDE report 9749736 ↗
• InjuryApr 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. ANTIBIOTIC SPACER IMPLANTED. DOI: UNKNOWN. DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7446153 ↗
• 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 7361441 ↗
• InjuryMar 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS TIBIAL PAIN. IT WAS ALSO REPORTED THAT THE PATIENT MENTIONED FALL AND THE SURGEON THOUGHT THAT THERE MIGHT BE SOME LOOSENING OF THE TIBIAL COMPONENT SO THE SURGEON ELECTED TO REVISE THE TIBIA. DOI: (B)(6) 2012; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 7348434 ↗
• InjuryJun 28, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATED THAT THE PATIENT EXPERIENCING INSTABILITY AND PAIN. PATIENT HAD A FALL AND DAMAGED TO PATELLAR TENDON WHICH HAD BEEN SURGICALLY REPAIRED. UPON EXAM IN OR, THE MCL WAS FOUND INCOMPETENT. ALL PARTS WERE REMOVED AND PATIENT CONVERTED TO A HINGE. NO INSTRUMENT WERE BROKEN.

  Patient problems: Pain

  MAUDE report 6674962 ↗