SIGMA 1024-08-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295001782), received between Oct 18, 2018 and Sep 4, 2025 — classified as 7 injuries.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE INITIAL SURGERY AND PAIN AFTER THE SURGERY. THIS PC REPORTS ABOUT THE REVISION SURGERY. IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN INITIAL SURGERY VIA UKA FOR OA ON MEDIAL CONDYLE OF RIGHT KNEE WITH THE PRODUCTS IN QUESTION. IN THE INITIAL SURGERY, A STANDARD HPP INTUITION MACHINE WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE INITIAL SURGERY, DURING A POSTOPERATIVE VISIT, THE PATIENT COMPLAINED OF PAINFUL DISCOMFORT. WHEN THE KNEE WAS EXTENDED AFTER DEEP FLEXION, THERE WAS A SYMPTOM LIKE A CRACKING SOUND. THAT SYMPTOM DID NOT OCCUR WHEN THE EXTENSION WAS PERFORMED FROM INTERMEDIATE FLEXION. IT WAS THOUGHT THAT THE INSERT WAS NOT DISLODGED, BUT RATHER THAT THE SOFT TISSUE WAS IMPINGING SOMEWHERE. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2025. AFTER REMOVING THE INSERT AND CHECKING THE SOFT TISSUE, A CEMENT FRAGMENT WAS EXTRACTED FROM THE REAR (THE CEMENT WAS OTHER COMPANIES' PRODUCTS). THIS WAS THOUGHT TO BE THE CAUSE, BUT IT WAS DISCOVERED THAT THE FE IMPLANT HAD LOOSENED, AND IT WAS REMOVED USING A KOCHER CLAMP. USING A 3-IN-1 CUT BLOCK (SRI), INSERT TWO BLOCK STABILIZE

  Patient problems: Discomfort; Pain

  MAUDE report 22965142 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR PAINFUL KNEE. UNI WAS LATERAL. PATIENT HAD MEDIAL WEAR AND PATELLA WEAR. DOI- (B)(6) 2020. DOR- (B)(6) 2024. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Pain

  MAUDE report 18920291 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SIGMA PARTIAL KNEE REVISION.

  Patient problems: Pain

  MAUDE report 11453977 ↗
• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY OPERATIVE NOTES (B)(6) 2016 INDICATE THE PATIENT RECEIVED A RIGHT UNI KNEE REPLACEMENT DUE TO MEDIAL COMPARTMENT OSTEOARTHRITIS AND HISTORY OF ACL INJURY. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. OFFICE NOTES (B)(6) 2018 INDICATE THE PATIENT IS EXPERIENCING INCREASING PAIN AND DIFFICULTY WITH AMBULATING. RADIOGRAPHS REVEAL A SOMEWHAT FLEXED POSITIONING OF THE FEMORAL COMPONENT AND ANTERIOR TRANSLATION OF THE TIBIAL COMPONENT, LATERAL COMPARTMENT OSTEOARTHRITIS IS ALSO PRESENT. REVISION OPERATIVE NOTES (B)(6) 2018 INDICATE THE PATIENT RECEIVED A CONVERSION TO RIGHT TOTAL KNEE ARTHROPLASTY DUE TO PAIN AND POSTERIOR CRUCIATE LIGAMENT RUPTURE. UPON ENTERING THE KNEE, IT WAS NOTED THAT BOTH COMPONENTS WERE NOT WORN, IN GOOD POSITION AND NOT LOOSE. THE KNEE ITSELF WAS NOTED TO BE UNSTABLE POSTERIORLY. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2016. DOR: (B)(6) 2018, RIGHT KNEE.

  Patient problems: Injury; No Code Available; Pain

  MAUDE report 9911690 ↗
• InjuryMar 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A RUPTURED POSTERIOR CRUCIATE LIGAMENT, DATE OF IMPLANTATION: (B)(6) 2016; DATE OF REVISION: (B)(6) 2018; (RIGHT KNEE).

  Patient problems: Ambulation or Postural Difficulties; Joint Disorder; No Code Available; Pain

  MAUDE report 9808305 ↗
• InjuryFeb 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO PAIN AND STIFFNESS. CONVERSION FROM UNI TO TKA. DOI: (B)(6) 2016; DOE:(B)(6) 2018, (RIGHT KNEE).

  Patient problems: Joint Disorder; No Code Available; Pain

  MAUDE report 8304365 ↗
• InjuryOct 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PAINFUL RIGHT KNEE. IMPLANTS REMOVED AND REVISED TO TOTAL.

  Patient problems: No Code Available; Pain

  MAUDE report 7980584 ↗