SIGMA 97-0462Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295250623), received between Jul 13, 2020 and Jan 5, 2026 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 23958226 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: IT WAS A DEPUY SIGMA OVAL DOME PATELLA. ALL MARKINGS TO IDENTIFY THE SIZE AND LOT WERE DESTROYED UPON REMOVAL.

  Patient problems: Pain

  MAUDE report 21410818 ↗
• MalfunctionOct 4, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE AFFECTED SIDE WAS THE RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20369084 ↗
• InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2017. DOR: (B)(6) 2023 . AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17019293 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MALE PT 67 YO, REQUIRED WASHOUT AND POLY LINER CHANGE OF HIS RTKR FOR INFECTION OF HIS RIGHT TOTAL KNEE REPLACEMENT. ORIGINAL SURGERY WAS DONE ON (B)(6) 2016. PT REQUIRED TWO WASHOUTS OF HIS INFECTED KNEE REPLACEMENT. FIRST ONE BEING ARTHROSCOPIC ON (B)(6) 2023 AND THEN AN OPEN WASHOUT AND EXCHANGE OF POLY LINE ON WEDNESDAY (B)(6) 2023. DOI: (B)(6) 2016. DOR (1ST): (B)(6) 2023. DOR (2ND): (B)(6) 2023.

  Patient problems: Unspecified Infection

  MAUDE report 16572123 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WASH OUT AND POLY EXCHANGE WERE PERFORMED DUE TO INFECTED KNEE. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16145874 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD WASHOUT FOR INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16140924 ↗
• InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED KNEES WITH THE POLY EXCHANGE. THERE WAS NO SURGICAL DELAY. THERE WAS NO LOOSENING REPORTED. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15347323 ↗
• InjuryJan 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF EXISTING PFC CURVED + SIZE 4 12.5MM TIBIAL INSERT. NEW 17.5MM SIZE 4 CURVED + TIBIAL INSERT IMPLANTED IN PATIENT. PATIENT WAS BEING REVISED DUE TO INSTABILITY THROUGHOUT GAIT. DOI: (B)(6) 2019. DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 13306793 ↗
• InjuryApr 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PAIN AND LOOSENING OF AN UNKNOWN COMPONENT HAS OCCURRED AGAIN. DEPUY CEMENT PRODUCTS WERE USED. THE DOCTORS ARE TRYING TO FIND OUT WHETHER THERE IS A POSSIBLE ALLERGY TO ONE OF THE COMPONENTS OF THE BONE CEMENT USED. THE DERMATOLOGIST/ALLERGIST NEEDED THE QUALITATIVE COMPOSITION COMPONENTS OR AT LEAST SAMPLES OF THE BONE CEMENT POWDER OR BONE CEMENT LIQUID FOR AN ALLERGY TEST. ON (B)(6) 2019, THE PATIENT UNDERWENT A PRIMARY LEFT KNEE ARTHROPLASTY WITH IMPLANTATION OF DEPUY UNICONDYLAR SLED PROTHESIS TO TREAT OSTEOARTHRITIS. DEPUY CEMENT WAS UTILIZED DURING THE PROCEDURE. THE PATELLA WAS NOT RESURFACED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2020, THE PATIENT UNDERWENT A LEFT KNEE REVISION TO ADDRESS PAIN, ADHESION, CYSTS, CREPITUS, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. ALL COMPONENTS WERE REMOVED, AND THE PATELLA WAS RESURFACED. ON (B)(6) 2021, A LEFT KNEE X-RAY REVEALED OSTEOLYSIS BENEATH THE TIBIAL PLATEAU. ON (B)(6) 2021, A LEFT KNEE CT REVEALED POSSIBLE TIBIAL TRAY LOOSENING. ON (B)(6) 2021, THE PATIENT UNDERWENT A LEFT KNEE ASPIRATION TO RULE OUT INFECTION DUE TO INCREASING PAIN. THE PHYSICIAN ASPIRATED 15

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 11618930 ↗
• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT KNEE.

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

  MAUDE report 10960122 ↗
• InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2018, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10364003 ↗
• InjuryJul 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. A WASHOUT WAS DONE. THE SURGEON USED TWO POLY INSERTS BECAUSE HE HAD TROUBLE WITH SOFT TISSUE GETTING IN THE WAY OF GETTING THE FIRST INSERT DOWN. DOI: (B)(6) 2019, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10264431 ↗