SIGMA 1024-07-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295001744), received between Jan 24, 2019 and Mar 2, 2026 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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. How this data works · Data updated Oct 13, 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.

• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT REPORTS THAT ON (B)(6) 2025 HE UNDERWENT A 1.5T LIVER MRI. THE PATIENT HAS A LEFT KNEE PROSTHESIS IMPLANTED ON (B)(6) 2025. DURING THE EXAMINATION, THE PATIENT REPORTS INITIALLY FEELING WARMTH, WHICH PROGRESSIVELY INTENSIFIED, REACHING ALMOST UNBEARABLE HEAT IN THE LOWER PART OF THE PATELLA OF THE LEFT KNEE (WHERE THE PROSTHESIS IS IMPLANTED). HE DOES NOT RECALL WHETHER THERE WAS REDNESS AT THE LEVEL OF THE KNEE. AFTER THE EXAMINATION, THE PATIENT CONTINUED TO EXPERIENCE SEVERE PAIN, UNTIL ON (B)(6) 2025 IT WAS DECIDED TO REPLACE THE PROSTHESIS WITH A NEW ONE (THE SURGERY WAS PERFORMED AT AN INSTITUTE DIFFERENT FROM HOSPITAL, THEREFORE WE DO NOT HAVE FURTHER DETAILS). THE DEVICE CARDS WERE REQUESTED (ATTACHED TO THE REPORT), AND BOTH ARE INDICATED BY THE COMPANY AS MRI SAFE. THE PROSTHESIS CONSISTS OF 3 COMPONENTS; ALL INDICATED ON THE ATTACHED LABELS.

  Patient problems: Inflammation; Pain

  MAUDE report 24484200 ↗
• InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SUFFERING FROM INFLAMMATION, BRUSHING, LACK OF MOTION AFTER A PARTIAL KNEE REPLACEMENT. DOI: (B)(6) 2022. DOE: JUN, 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inflammation; Loss of Range of Motion; Pain

  MAUDE report 19331675 ↗
• InjuryFeb 16, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT EXPERIENCED ASEPTIC MOBILIZATION. DOI: (B)(6) 2021; DOE: (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 18721250 ↗
• InjurySep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY LM UNICOMPARTMENTAL KNEE SURGERY ON (B)(6) 2020 WHEN A SIGMA PARTIAL KNEE WAS UTILIZED (DR (B)(6), (B)(6)). PATIENT PRESENTED WITH A PAINFUL KNEE AND THE TIBIAL COMPONENT WAS REVISED ON (B)(6) 2021 (DR (B)(6), (B)(6) HOSPITAL) (SEE (B)(4)). PATIENT INITIALLY DID WELL AND PRESENTED AGAIN WITH A PAINFUL KNEE - THIS RESULTED ON A POLY EXCHANGE OF THE TIBIAL COMPONENT AND A WASHOUT ON (B)(6) 2021 (DR (B)(6), (B)(6)) (SEE (B)(4)). PATIENT WAS THEN DOING WELL UNTIL APPROXIMATELY 6 MONTHS AGO WHEN HE STARTED TO EXPERIENCE A PAINFUL KNEE. A DECISION WAS MADE TO REVISE THE SIGMA PARTIAL TO A TOTAL KNEE WITH A STEM AND SLEEVED TIBIA. ON OPENING THE KNEE ((B)(6) 2022, DR (B)(6), (B)(6) HOSPITAL) THE TIBIAL COMPONENT WAS FOUND TO BE LOOSE - WITH THE FAILURE AT THE BONE CEMENT/ BONE INTERFACE. ALL COMPONENTS WERE REMOVED AND STEMMED AND SLEEVED ATTUNE REVISION TIBIAL COMPONENT IMPLANTED ALONG WITH A PRIMARY PS FEMORAL COMPONENT. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? UNKNOWN, IF YES, PLEASE DESCRIBE. LOOSE TIBIAL COMPONENT - REVISION TO TOTAL KNEE , DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROS

  Patient problems: Pain; Unspecified Infection

  MAUDE report 15485729 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR CONTINUED DRAINAGE. EXPLANTED SZ 4 LM FEMUR, THE SZ 4 LM TIBIAL TRAY AND SZ 4, 8MM TIBIAL INSERT. WASHOUT WAS CONDUCTED, ANTIBIOTICS ADMINISTERED. IMPLANTED A NEW SZ 4 LM FEMUR, AND A SZ 4,11MM INSERT. PREVIOUS WASHOUT ON (B)(6) 2022 RESULTED IN ONLY AN INSERT SWAP OUT. REPORT WAS CREATED. NO DELAY IN SURGERY. NO INJURY TO PATIENT. THIS WAS THE LEFT KNEE. ORIGINAL DOS WAS (B)(6) 2022. DOI: (B)(6) 2022. DOR: (B)(6) 2022. LEFT KNEE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 14690022 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT KNEE TKA EXPLANATION FOR INFECTION. CEMENT NOT FROM DEPUY. REVISION/REMOVAL OF HARDWARE COMPLETED.

  Patient problems: Unspecified Infection

  MAUDE report 13023421 ↗
• 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 12240316 ↗
• InjuryApr 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF AN UNKNOWN COMPONENT. UNKNOWN CEMENT WAS USED. 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. DEPUY PRODUCTS WERE IMPLANTED WITH DEPUY CEMENT. 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 ML OF BLOOD-TINGED CLEAR EFFUSION AND SENT FOR MICROBIOLOGY AND CELL COUNT. RESULTS OF ASPIRATION NOT GIVEN WITHIN THE AVAILABLE MEDICAL RECORDS. THE PHYSICIAN ALSO INDICATED A REQUEST FOR ALLERGY TESTING FOR THE BONE CEMENT. NO RESULTS AVAILABLE R

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cyst(s); Pain

  MAUDE report 11618850 ↗
• InjuryMar 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DEPUY CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2013, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11444305 ↗
• InjuryOct 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS REVIEWED. ON (B)(6) 2016, PATIENT RECEIVED A MEDIAL LEFT KNEE UNICOMPARTMENTAL ARTHROPLASTY, TO ADDRESS MEDIAL COMPARTMENT OSTEOARTHRITIS. THERE WAS NO REPORTED COMPLICATION. ON (B)(6) 2018, PATIENT'S LEFT KNEE WAS REVISED TO ADDRESS PAIN AND SUSPECTED IMPLANT LOOSENING. IT WAS DETERMINED THOUGH, THAT THERE WAS NO IMPLANT LOOSENING--BOTH FEMUR AND TIBIAL TRAY COMPONENTS WERE WELL-FIXED. RATHER, IT WAS IDENTIFIED THAT THE TIBIAL INSERT COMPONENT LOCKING MECHANISM HAD PARTIALLY FAILED, WITH THE INSERT MOVING IN THE TRAY. THIS INSERT COMPONENT WAS REVISED, AND SCAR TISSUE EXCISED.

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

  MAUDE report 9221444 ↗
• MalfunctionJan 24, 2019Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  ARRIVED WITH A HOLE IN THE PACKAGING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8273654 ↗