SIGMA 94-0019Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295223450), received between Jun 12, 2019 and Apr 28, 2025 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (2 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 18, 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.

• InjuryApr 28, 2025Improper or Incorrect Procedure or Method; Naturally Worn; Improper or Incorrect Procedure or Method; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT REVISION SURGERY. THE PATIENT HAS A GENESIS KNEE INSITU FROM COMPETITOR. THE POLY HAS WEAR ON BOTH SIDES POSTERIORLY. THERE IS ALSO WEAR ON THE POSTERIOR ASPECT OF THE TIBIAL TRAY. THERE WAS METALOSIS IN THE TISSUE AND VISIBLE POLY DEBRIS. THERE WAS EXTENSIVE OSTEOLYSIS OF THE FEMUR AND THE SURGEON STATED THAT THE METAPHYSIS WAS ¿EGG SHELL¿ AND PARTIALLY MISSING. SURGEON CLEANED THE AREA OF DEBRIS AND AFFECTED BONE AND AN ATTUNE REVISION WAS USED WITH METAPHYSEAL SLEEVES ON BOTH THE FEMUR AND TIBIAL, WITH STEMS, AND AUGMENTS AND A CRS POLY. THE PRIMARY SURGERY WAS DONE APPROXIMATELY 13-19 YEARS AGO. IT WAS FURTHER REPORTED THAT THERE WAS OFF-LABEL USAGE IN PRIMARY PROCEDURE. THE POLY SIZE SHOULD MATCH THE FEMUR BUT IN THIS CASE THE POLY MATCHES THE TIBIA. THERE WAS A 4N FEMUR INSITU AND A SIZE 3 POLY AND A SIZE 3 TIBIAL TRAY. IT SHOULD HAVE BEEN A SIZE 4 POLY.

  Patient problems: Foreign Body Reaction; Osteolysis

  MAUDE report 21922323 ↗
• InjuryOct 19, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO PAIN AND LOOSENING OF THE FEMUR AND TIBIA AT BONE TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS DEPUY. DOI: UNKNOWN DOR: (B)(6) 2023 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 17967532 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO INSTABILITY AND PAIN. DOI: UNKNOWN, DOR: (B)(6) 2022, LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 15564196 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. PLEASE PROVIDE THE LOT NO. OF SIG C/R POROCOAT FEM LT SZ 4N (9400190) AND MBT CEM KEEL TIB TRAY SZ3(129433130). LOT. FEM. 382505 / LOT TIBIA 6712886. B. WHAT IS THE REVISION DATE? (B)(6) 2022. C. CAN YOU CONFIRM THE PRIMARY SURGERY DATE OR THE ORIGINAL IMPLANTATION DATE? (B)(6) 2020. D. CAN YOU PLEASE PROVIDE THE DATE IF THE PATIENT WAS REVISED? (B)(6) 2022. E. WAS/WERE THE BONE CEMENT/S USED DEPUY MANUFACTURED? IF YES, PLEASE PROVIDE THE QUANTITY, PRODUCT AND LOT NUMBERS. NA. F. WAS SURGERY TIME EXTENDED? IF YES, WHAT IS THE DURATION OF THE DELAY? NO.

  Patient problems: Fall; Joint Laxity; Pain; Unspecified Musculoskeletal problem

  MAUDE report 13772846 ↗
• MalfunctionJan 18, 2022Use of Device Problem; Use of Device Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT KNEE TO ADDRESS INSTABILITY. DATE OF IMPLANTATION: (B)(6) 2020. DATE OF REVISION: (B)(6) 2021. (LEFT KNEE). TREATMENT: REVISION OF INSERT COMPONENT. DOR: (B)(6) 2021. PATIENT RECEIVED A REVISION OF THE LEFT KNEE INSERT TO TREAT PAIN SECONDARY TO GLOBAL INSTABILITY. UPON ENTERING THE JOINT, A COMPLETE SYNOVECTOMY WAS PERFORMED, AND THE INSTABILITY WAS CONFIRMED. AFTER THE INSERT WAS REVISED, THE SURGEON NOTES THAT THERE WAS STILL MINIMAL VARUS/VALGUS INSTABILITY SECONDARY TO A SLIGHTLY INTERNALLY ROTATED FEMORAL COMPONENT. THE SURGEON DID NOT ELECT TO REVISE THE FEMORAL COMPONENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: UNK. DOR: (B)(6) 2021 LEFT KNEE INSERT.

  Patient problems: Joint Laxity; Pain

  MAUDE report 13283040 ↗
• InjuryOct 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD LEFT KNEE REVISION DUE TO INFECTION. ALL IMPLANTS REMOVED. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12640738 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR EXPRACAPSULAR DRAINAGE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021, DATE OF EVENT (ONSET): (B)(6) 2021, (LEFT KNEE). TREATMENT: PLACEMENT IN KNEE IMMOBILIZER AND RECHECK WOUND IN TWO DAYS. ON (B)(6) 2021 THE PATIENT HAD A LEFT HYBRID TOTAL KNEE ARTHROPLASTY TO ADDRESS PRIMARY OSTEOARTHRITIS, END-STAGE. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA, ALONG WITH DEPUY CEMENT WERE USED DURING THIS PROCEDURE. ON (B)(6) 2021 PATIENT WAS ADMITTED TO HOSPITAL FOR SEPSIS, WHICH THE SURGEON NOTED THAT ¿THEY THINK IS COMING FROM HER GALLBLADDER¿.

  Patient problems: Fluid Discharge; Sepsis

  MAUDE report 12200580 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR - DVT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2020, (LEFT KNEE). TREATMENT: ELIQUIS, AFTER SOME COUMADIN AND LOVENOX.

  Patient problems: Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 11087155 ↗
• InjuryJul 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT UNDERWENT A PRIMARY LEFT KNEE REVISION WITH NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON(B)(6) 2020, THE PATIENT PRESENTED FOR A LEFT KNEE EVALUATION DUE TO ADHESIONS/ARTHROFIBROSIS, SLIGHT INSTABILITY, DECREASED RANGE OF MOTION, AND NON-PROGRESSING PHYSICAL THERAPY. ON (B)(6) 2020, THE PHYSICIAN NOTED THE PATIENT WAS CONTINUING PHYSICAL THERAPY WITH IMPROVING RANGE OF MOTION. ON (B)(6) 2020, THE PATIENT UNDERWENT A LEFT KNEE CLOSED MANIPULATION UNDER ANESTHESIA DUE TO ADHESIONS/ARTHROFIBROSIS AND STIFFNESS. THE PROCEDURE WAS COMPLETED WITHOUT APPARENT INTRA-OPERATIVE COMPLICATIONS. NO PRODUCTS WERE REVISED.

  Patient problems: Adhesion(s); Limited Mobility Of The Implanted Joint; Muscular Rigidity; No Code Available

  MAUDE report 10352245 ↗
• InjuryMay 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. NO SURGICAL DELAY. DOI: (B)(6) 2019; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10102700 ↗
• InjuryJun 12, 2019Use of Device Problem; Use of Device Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION - MALPOSITION/MALALIGNMENT : PATELLA SUBLUXATION. DOI: (B)(6) 2017; DOR: (B)(6) 2017; (LEFT KNEE).

  Patient problems: No Code Available

  MAUDE report 8691349 ↗