SIGMA 94-0024Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295223481), received between Sep 22, 2017 and Jul 31, 2026 — classified as 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 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 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.

• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient had a stiff knee. The doctor revised the construct except the patella to an Attune CRS W Short Stems on both the Fem and the tibia. DOI: Unknown.DOR: (b)(6) 2026.Affected Side: Unknown Knee.

  Patient problems: Muscular Rigidity

  MAUDE report 50100961 ↗
• InjuryMay 7, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. DARTMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO LOOSENING AND SUBSIDENCE OF TIBIAL AND FEMORAL COMPONENTS. FEMORAL COMPONENT WAS PRESSFIT. THERE WAS NO CEMENT ON THE TIBIAL COMPONENT. OSTEOLYSIS AND PAIN WERE ALSO REPORTED. UNKNOWN IF THE PATELLA WAS RESURFACED.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21979731 ↗
• InjuryAug 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2009; DATE OF REVISION: (B)(6) 2016; DATE OF REVISION: (B)(6) 2022; (RIGHT KNEE). TREATMENT: REVISION; INSERT REMOVED.

  Patient problems: Fluid Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15183500 ↗
• InjuryMay 13, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SPIN OUT VS INSTABILITY WITH PCL COMPROMISE EVENT IS SERIOUS AND IS CONSIDERED SEVERE EVENT IS DEFINITELY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2022 DATE OF EVENT (ONSET): (B)(6) 2022 DATE OF REVISION: (B)(6) 2022 (RIGHT KNEE) TREATMENT: REVISION OF TIBIAL INSERT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 14399790 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. REMOVAL OF ALL COMPONENTS. DATE OF IMPLANT: (B)(6) 2016; DATE OF IMPLANT (INSERT): (B)(6) 2022; DATE OF REVISION: (B)(6) 2022 ; (RIGHT KNEE).

  Patient problems: Unspecified Infection

  MAUDE report 14193986 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LATERAL ABSCESS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2009. DATE OF IMPLANT INSERT: (B)(6) 2016. DATE OF EVENT: (B)(6) 2022. (RIGHT KNEE). TREATMENT: IRRIGATION AND DEBRIDEMENT.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 14083843 ↗
• InjuryApr 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE INSTABILITY EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2021, (RIGHT KNEE). TREATMENT: PHYSICAL THERAPY, WITH POSSIBLE CONSIDERATION FOR REVISION IN THE FUTURE.

  Patient problems: Joint Laxity

  MAUDE report 11679973 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  ON (B)(6) 2020, THE PATIENT UNDERWENT BILATERAL PRIMARY KNEE ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS. DEPUY PRODUCTS AND CEMENT WERE UTILIZED IN BOTH KNEES. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2021, THE PATIENT PRESENTED FOR A BILATERAL KNEE EVALUATION. IN THE RIGHT KNEE, THE PATIENT WAS EXPERIENCING PAIN, DISCOMFORT, SWELLING, AND A PALPABLE POP WHEN GOING FROM FLEXION TO EXTENSION. ON (B)(6) 2021, THE PATIENT UNDERWENT A RIGHT KNEE ARTHROTOMY WITH OSTECTOMY OF HETEROTOPIC BONE OF DORSAL FEMUR. THE SURGEON NOTED A SIGNIFICANT AMOUNT OF CREPITUS UNDER THE EXTENSOR MECHANISM OF THE RIGHT KNEE. THE SURGEON ALSO NOTED EXCISING MODERATE HYPERTROPHIC SYNOVITIS. NO PRODUCTS WERE REVISED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2021, THE PATIENT PRESENTED FOR A POST-OPERATIVE EVALUATION OF THE RIGHT KNEE. THE PATIENT WAS NOTED TO BE DOING VERY WELL WITH NO ISSUES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Calcium Deposits/Calcification; Discomfort; Pain; Swelling/ Edema; Synovitis

  MAUDE report 11516718 ↗
• InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RUPTURE PATELLAR TENDON - EXTENSOR MECHANISM INSUFFICIENCY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND POSSIBLE RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2020. DATE OF EVENT: (B)(6) 2021. DATE OF REVISION: (B)(6) 2021. (RIGHT KNEE). ON (B)(6) 2020, THE PATIENT UNDERWENT A BILATERAL KNEE ARTHROPLASTY TO ADDRESS BILATERAL OSTEOARTHRITIS. DEPUY PRODUCTS AND CEMENT WERE IMPLANTED IN BOTH KNEES. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2021, THE PATIENT UNDERWENT A RIGHT KNEE SURGICAL INTERVENTION TO ADDRESS PATELLA TENDON RUPTURE. THE SURGEON NOTED MODERATE EFFUSION. THE PATELLA TENDON RUPTURE WAS REPAIRED WITH THE PLACEMENT OF A TENSION BAND WIRE. NO PRODUCTS WERE REVISED. THE SURGEON NOTED THE PATIENT WOULD BE PLACED IN A LONG LEG CAST THE DAY FOLLOWING THE OPERATION. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS.

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

  MAUDE report 11436547 ↗
• InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS A SPIN-OUT OF THE POLY. A REPLACEMENT WITH A THICKER POLY WAS DONE ON (B)(6) 2020. THE SURGEON WANTED TO PUT A MORE STABLE CONSTRUCT IN. DOI: (B)(6) 2020, DOI: (B)(6) 2020 (INSERT), DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11116789 ↗
• MalfunctionFeb 25, 2020Noise, Audible; Noise, Audible

  ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO INFECTION, ERYTHEMA, DRAINAGE, DEHISCENCE, AND EDEMA. A TIBIAL INSERT EXCHANGE AND IRRIGATION AND DEBRIDEMENT WERE PERFORMED. THIS WAS CAPTURED IN (B)(4). ON (B)(6) 2020, THE PATIENT PRESENTED FOR A RIGHT KNEE EVALUATION DUE TO CLUNKING IN THE KNEE, PAIN, INSTABILITY, AND POSSIBLE SPIN OUT OF THE TIBIAL INSERT. THERE IS NO EVIDENCE OF A SECOND REVISION OR INVASIVE TREATMENT AFTER THE FIRST REVISION.

  Patient problems: No Code Available; Pain

  MAUDE report 9749846 ↗
• MalfunctionFeb 12, 2020Noise, Audible; Patient Device Interaction Problem; Noise, Audible; Patient Device Interaction Problem

  ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO INFECTION, ERYTHEMA, DRAINAGE, DEHISCENCE, AND EDEMA. A TIBIAL INSERT EXCHANGE AND IRRIGATION AND DEBRIDEMENT WERE PERFORMED. ON (B)(6) 2020, THE PATIENT PRESENTED FOR A RIGHT KNEE EVALUATION DUE TO CLUNKING IN THE KNEE, PAIN, INSTABILITY, AND POSSIBLE SPIN OUT OF THE TIBIAL INSERT. THERE IS NO EVIDENCE OF A SECOND REVISION OR INVASIVE TREATMENT AFTER THE FIRST REVISION. THIS PC WAS TO CAPTURED RIGHT KNEE EVALUATION ON (B)(6) 2020.

  Patient problems: Pain

  MAUDE report 9701745 ↗
• InjurySep 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY.

  Patient problems: No Code Available; Pain

  MAUDE report 6886400 ↗