SIGMA 1024-53-207Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295002482), received between Apr 25, 2018 and Mar 8, 2022 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 13686028 ↗
• InjuryDec 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION UKA FOR ANTERO-MEDIAL TIBIAL IMPACTION. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? YES, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES, HARDWARE/EXPLANT REMOVAL DUE TO: PAIN, IF YES, DATE OF REVISION SURGERY. (B)(6) 2021, REASON FOR REVISION SURGERY. PAIN, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? PAIN.

  Patient problems: Pain

  MAUDE report 12953640 ↗
• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS KNEE PAIN. NO SURGICAL DELAY. DOI: (B)(6) 2016; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 12240306 ↗
• MalfunctionJun 24, 2021Difficult to Insert; Difficult to Insert

  PATIENT WAS REVISED DUE TO TIBIAL INSERT WOULDN'T SEAT IN THE TIBIAL TRAY. DOI: UNKNOWN DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12063788 ↗
• InjuryApr 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN I & D WAS PERFORMED ON PATIENT FOR INFECTION. SURGEON EXPLANTED THE UNI TIBIAL INSERT AND WASHOUT THE KNEE. IMPLANTED A NEW SZ 2, 7MM LM UNI INSERT.

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

  MAUDE report 11648736 ↗
• InjuryDec 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNI KNEE INSTALLED IN (B)(6) 2020. FOLLOWING CEMENT REMAINING IN THE JOINT, THE SURGEON PROCEEDED TO REMOVE THE INSERT TO REACH THE CEMENT REMAINS. CLEANING AND PLACEMENT OF A NEW INSERT.

  Patient problems: Pain

  MAUDE report 11064597 ↗
• InjuryAug 30, 2019Naturally Worn; Naturally Worn

  PATIENT WAS REVISED TO ADDRESS PAIN AND WEARING DOWN THE LATERAL COMPARTMENT OF THE LEFT KNEE. SURGEON REMOVED THE UNI COMPONENTS AND REPLACED WITH A TOTAL KNEE. NO ACCESS TO THE CEMENT USED BUT KNOW IT WAS A 20G BATCH OF FAST SETTING BONE CEMENT. DOI: (B)(6) 2018, DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8951784 ↗
• MalfunctionOct 1, 2018Fitting Problem; Fitting Problem

  INSERT WAS NOT LOCKING ON TIBIAL IMPLANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7923888 ↗
• InjuryApr 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR PAIN AND OSTEOLYSIS. REMOVED THE UNI FEMORAL, TIBIAL, AND TIBIAL INSERT. IMPLANTED A SIZE 4N SIGMA FEMUR WITH AUGMENTS, FEMORAL SLEEVE AND PRESSFIT STEM. THE TIBIA WAS IMPLANT WITH A SIZE 3 FIXED BEARING COCR TRAY WITH A SIZE 3,8MM FIXED BEARING INSERT. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: Not Applicable; Osteolysis; Pain

  MAUDE report 7457534 ↗