SIGMA 1960-40-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10603295075073), received between Jan 15, 2018 and Feb 3, 2025 — classified as 34 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (6 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT FEMUR WAS REVISED DUE TO THIGH PAIN. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21294683 ↗
• MalfunctionNov 5, 2024Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT PATIENT UNDERWENT KNEE SURGERY ON (B)(6) 2024. OPENING THE IMPLANT WAS DIFFICULT; THE SECOND PACKAGING DID NOT OPEN EASILY, CAUSING THE IMPLANT TO FALL TO THE GROUND, MAKING IT IMPOSSIBLE TO USE. ANOTHER IMPLANT WAS USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIVE MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20610057 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: ON (B)(6) 2023, PATIENT'S LEFT KNEE WAS REVISED WITH COMPLETE EXPLANTATION OF IMPLANTS AND PLACEMENT OF AN ANTIBIOTIC LOADED SPACER (SURESPACE TIBIAL AND FEMORAL COMPONENTS, ALONG WITH 6 PACKAGES OF DEPUY 2 GENTAMYCIN CEMENT AND ADDITIONAL POWDERED VANCOMYCIN (MANUFACTURER UNSPECIFIED) FOR A TOTAL OF 12 GRAMS OF VANCOMYCIN ADDED TO DEPUY 2 CEMENT), TO ADDRESS RECURRENT CHRONIC INFECTION (ADDITIONALLY, AN UNKNOWN MANUFACTURER'S HIGH TIBIAL OSTEOTOMY STAPLE WAS ALSO REMOVED, USING A SEPARATE INCISION). EXPLANTATION OF COMPONENTS CAUSED MINIMAL TO MODERATE BONE LOSS--A NORMAL EXPECTATION OF REVISION SURGERY. THE PATIENT TOLERATED THE PROCEDURE WELL, WITH NO COMPLICATIONS. THE MEDICAL RECORDS APPEAR TO PROVIDE NO NEW INFORMATION THAT IMPACTS PRIOR PRODUCT AND CODING ASSIGNMENTS, NOR CHANGE THE EXISTING REPORTABILITY DETERMINATIONS.

  Patient problems: Unspecified Infection

  MAUDE report 18463791 ↗
• InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO MULTIPLE INFECTIONS SINCE THE ORIGINAL TKA WAS DONE. EXPLANTED AND A CEMENT SPACER WAS PUT IN. NO SURGICAL DELAY. DOI: (B)(6) 2013. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17807649 ↗
• InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR SUSPECTED FAILED SUPPRESSION; DEEP INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. DATE OF IMPLANT: (B)(6) 2013. DATE OF REVISION #1: (B)(6) 2018. DATE OF REVISION #2: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: ASPIRATION/DRAINAGE.

  Patient problems: Unspecified Infection

  MAUDE report 17711154 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO LOOSENING. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17395563 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH INFECTION. ANTIBIOTIC SPACER PLACED IN PATIENT. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17324436 ↗
• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO RESECTION FOR INFECTION. IT WAS GROUP B STREP. ACTIVITY LEVEL WAS YES. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2018. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16921012 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTES INDICATE THAT ON (B)(6) 2023 THE PATIENT HAD A LEFT KNEE ASPIRATION: MEDICAL RECORDS REPORT THAT INFLAMMATION MARKERS WERE SLIGHTLY ELEVATED WITH A SEDIMENTATION RATE OF 43 AND C-REACTIVE PROTEIN IS 28. THE PATIENT¿S LEG IS NOTED TO BE SWOLLEN AND THE PATIENT REPORTS HAVING PAIN. THERE IS MODERATE EFFUSION. THE PATIENT REPORTED THAT THEY HAD A TRAUMA WHERE THEY WERE HANGING FROM HIS KNEE FOR AN HOUR, SO THE SWELLING COULD BE HEMARTHROSIS AND SECONDARY SYNOVITIS. THE PATIENT IS ON ANTIBIOTICS AND AN ASPIRATION WAS ORDERED. ON (B)(6) 2023, MEDICAL RECORDS NOTE THE PATIENT¿S KNEE IS INFECTED WITH STAPH. THE SURGEON IS PLANNING ON DOING A POLY SWAP WITH IRRIGATION. THE CLINICAL DATABASE INDICATES A REVISION OF THE LEFT KNEE WAS COMPLETED ON (B)(6) 2023 AS A TREATMENT FOR INFECTION. THE INSERT WAS REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 16742601 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION FOR PATELLA RESURFACING. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? NO, DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? YES, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES, FACILITY NAME OF ORIGINAL IMPLANT : (B)(6), WAS DEVICE EXPLANTED? TRUE, HARDWARE/EXPLANT REMOVAL DUE TO: PAIN, DID PATIENT REQUIRE REVISION SURGERY? TRUE, IF YES, DATE OF REVISION SURGERY. (B)(6) 2021, REASON FOR REVISION SURGERY: PAIN.

  Patient problems: Pain

  MAUDE report 13011347 ↗
• InjuryDec 15, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION COMPLETED SECONDARY TO LOOSENING OF THE FEMORAL AND TIBIAL COMPONENT AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. FEMORAL COMPONENT HAD CEMENT ON POSTERIOR CONDYLES ONLY. TIBIAL TRAY HAD SOME CEMENT ON UNDERSIDE OF TRAY. PATELLA WAS WELL FIXED AND NOT REVISED. DOI: 2015, DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 13010289 ↗
• InjuryDec 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION AND SOME TYPE OF CANCER. ALL IMPLANTS REMOVED. NO OTHER AVAILABLE INFORMATION. NO SURGICAL DELAY. DOI: (B)(6) 2018, DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12975529 ↗
• InjuryAug 18, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDICAL RECORDS RECEIVED AND WERE REVIEWED: OPERATIVE NOTES 04/02/2021 INDICATE THE PATIENT RECEIVED A LEFT KNEE ARTHROSCOPY DUE TO PAIN, PATELLAR CLUNK, CREPITUS, INSTABILITY, DIFFICULTY AMBULATING AND ABUNDANT SCARRING WITHIN THE JOINT. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information; Joint Laxity; Pain

  MAUDE report 12336497 ↗
• InjuryJun 16, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WAS REVISED TO ADDRESS PATELLA CLUNK. SURGERY TIME WAS NOT EXTENDED. DOI: (B)(6) 2019. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12013537 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALL IMPLANTS REMOVED AND SPACER PLACED TO TREAT INFECTION. DOI: (B)(6) 2019, DOR: UNKNOWN, INFECTED LEFT KNEE.

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

  MAUDE report 11691384 ↗
• InjuryApr 5, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENT AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2014, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11613855 ↗
• InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THE PATIENT HAD A LEFT CEMENTED TOTAL KNEE ARTHROPLASTY TO ADDRESS PRIMARY END-STAGE LEFT KNEE, SEVERE WITH SEVERE VARUS DEFORMITY AND MEDIAL TIBIAL BONE LOSS. CONTRACTURES WERE NOTED DURING THE PROCEDURE. ON (B)(6) 2017, THE PATIENT HAD A REVISION LEFT TOTAL KNEE TIBIAL COMPONENTS TO ADDRESS INFECTED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO CONTIGUOUS INFECTION AND BREAKDOWN OF LEFT TOTAL KNEE ARTHROPLASTY WOUND. ONLY THE INSERT WAS REVISED. ON (B)(6) 2017, THE PATIENT HAD A LEFT ABOVE THE KNEE AMPUTATION TO ADDRESS CHRONIC RECALCITRANT LEFT TOTAL KNEE ARTHROPLASTY INFECTION. GROSS PUS WAS FOUND WITHIN THE KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Perforation of Vessels; Unspecified Tissue Injury

  MAUDE report 11413044 ↗
• InjuryFeb 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2021; RIGHT KNEE.

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

  MAUDE report 11358449 ↗
• InjuryFeb 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SEVERAL NOTATIONS THAT POST REVISION SURGERY (PROCEDURE ON (B)(6) 2018) PATIENT REPORTS PAIN IN ANTERIOR ASPECT OF LEFT KNEE AND GENERALIZED SWELLING AFTER LONG PERIODS OF STANDING, WALKING AND STAIR CLIMBING BEING MANAGED WITH MEDICATION AND NSAIDS. PATIENT REQUESTED NON-SURGICAL AND CONSERVATIVE MANAGEMENT TO ADDRESS PAIN IN L KNEE/LOW BACK AND REPORTS WILLINGNESS TO ACCEPT INJECTIONS (NOTED ON (B)(6) 2019). PATIENT REPORTS SOME L KNEE PAIN RELIEF SECONDARY TO LUMBAR INJECTION (LESI PROCEDURE ¿ SPINE EPIDURAL STEROID INJECTION) ADMINISTERED ON (B)(6) 2019. PROGRESS NOTE DOCUMENTS THAT THE CHRONIC LOW BACK PAIN AND RADICULOPATHY CONTRIBUTES TO THE REPORTED L KNEE PAIN (NOTED ON 10/04/2019). PATIENT RECEIVES PHYSICAL THERAPY FROM (B)(6) /2019 TO ADDRESS PAIN AND BILATERAL HIP FLEXOR WEAKNESS WITH DIAGNOSIS OF LUMBAR RADICULOPATHY. LATEST RADIOLOGICAL REPORTS ((B)(6) 2020) REPORT SMALL JOINT EFFUSION BUT NO LOOSENING AS PREVIOUSLY SUGGESTED IN PRIOR REPORT (DATED (B)(6) 2019). DOI: (B)(6) 2015 (FEMUR AND PATELLA), DOI: (B)(6) 2018 (CEMENT, INSERT AND TIBIAL COMPONENTS), DOR: UNKNOWN, LEFT KNEE.

  Patient problems: Fatigue; Pain; Swelling/ Edema

  MAUDE report 11327471 ↗
• InjuryDec 18, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2018, THE PATIENT HAD A REVISION LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS LOOSENING OF THE TIBIAL TRAY AT THE CEMENT/IMPLANT INTERFACE, PAIN, SWELLING, AND DIFFICULTY WITH WALKING. THE PATELLA AND FEMORAL COMPONENTS WERE NOTED TO BE WELL-FIXED AND WERE RETAINED. THE INSERT WAS REMOVED WITHOUT ALLEGATION OF DEFICIENCY. DEPUY TIBIAL TRAY AND INSERT WERE USED AS WELL AS COMPETITOR CEMENT X2 WERE USED DURING THIS PROCEDURE. ON (B)(6) 2019, THE PATIENT HAD A REVISION LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS FAILED LEFT TOTAL KNEE ARTHROPLASTY AND LOOSE LEFT TOTAL KNEE ARTHROPLASTY. THE INDICATIONS FOR SURGERY INCLUDED: ONE BAG OF DEPUY CEMENT USED FOR BOTH KNEES DURING INITIAL IMPLANTATION, WHICH LED TO EARLY FAILURE AND HAS HAD A PREVIOUS REVISION FOR LOOSE TIBIAL. PRIOR MEDICAL RECORDS NOTED THE PATIENT WAS EXPERIENCING INSTABILITY, AND PAIN. DURING THE CURRENT REVISION THE SURGEON REPORTED THAT THE FEMORAL COMPONENT AND PATELLA WERE LOOSE, NO INTERFACE PROVIDED. DEPUY FEMORAL COMPONENT, PATELLA, AND INSERT, ALONG WITH COMPETITOR CEMENT X2 WERE USED DURING THIS PROCEDURE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11037707 ↗
• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION IN THE LEFT KNEE. SURGEON REMOVED ALL IMPLANTS AND PLACED AN ANTIBIOTIC SPACER. LOT NUMBERS WERE COVERED BY CEMENT, UNREADABLE. DOI: UNKNOWN. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9938094 ↗
• InjuryJan 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PAINFUL LEFT KNEE. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2008; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9580617 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REASON FOR REVISION: INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9401377 ↗
• InjuryNov 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS KNEE WAS BELIEVED TO BE INFECTED. COMPONENTS REMOVED AND REPLACED IN A ONE STAGE REVISION WITH PLACEMENT OF ANTIBIOTIC BEADS. NO LOT AVAILABLE FOR CEMENT AS IT IS HOSPITAL INVENTORY. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9297342 ↗
• InjuryNov 7, 2019Noise, Audible; Noise, Audible

  THE PATIENT WAS REVISED TO ADDRESS CREPITUS, SWELLING, INSTABILITY, PAIN AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AT THE BONE TO CEMENT INTERFACE. UNKNOWN CEMENT USED. DOI: (B)(6) 2013. DOR: (B)(6) 2019. LEFT KNEE.

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 9290382 ↗