SIGMA 96-2362Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295242499), received between Aug 29, 2017 and Dec 16, 2025 — classified as 22 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PERIPROSTHETIC KNEE JOINT INFECTION. SURGEON CHANGED POLY AND PERFORMED I&D.

  Patient problems: Unspecified Infection

  MAUDE report 23815406 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 PATIENT HAD A KNEE REVISION AT HOSPITAL. SUBSEQUENTLY, THE PATIENT'S LEFT KNEE SHOWED SIGN OF INFECTION. SURGEON PERFORMED A POLY SWAP WITH I&D ON (B)(6) 2024. CASE WENT WITHOUT INCIDENT. DOI: (B)(6) 2018. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21067204 ↗
• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ORIGINAL IMPLANT INSERTED IN 2001 (NO RECORDS AVAIL). PATELLA & POLY REVISION IN 2011. FULL REVISION (NOT THE PATELLA) DONE (B)(6) 2015. PATIENT PRESENTED RECENTLY WITH INCREASING PAIN AND DECREASED RANGE OF MOTION. DURING THIS REVISION SURGERY ALL COMPONENTS WERE FOUND TO BE WELL FIXED. THE PATELLA HAD A GREAT DEAL OF WEAR AND WAS REVISED AND A POLY EXCHANGE WAS PERFORMED. DOI: (B)(6) 2011. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 14303708 ↗
• InjuryJan 4, 2022Off-Label Use; Appropriate Device Problem Term/Code Not Available; Off-Label Use; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2019, THE PATIENT HAD A RIGHT TOTAL KNEE REVISION TO ADDRESS PAIN, DISCOMFORT, INSTABILITY, DUE TO TRAUMA, SWELLING, AND DIFFICULTY WALKING. THE PATIENT¿S PAST SURGICAL HISTORY INCLUDED RIGHT KNEE SURGERY X4. DURING THIS PROCEDURE THE INSERT WAS REVISED. DEPUY COMPONENT TIBIAL TRAY WITH THE TIP OF THE POST APPROXIMATELY 8MM REMOVED. THE REAL POLY WAS NOW INSERTED AND THE TIP OF THE POST OF THE POLYETHYLENE WAS REMOVED, SO IT DID NOT IMPINGE IN THE BOX" (STICKER PAGE 352 OF 374). DOI: UNK, DOR: (B)(6) 2019, AFFECTED SIDE: RIGHT KNEE . THIS COMPLAINT WAS LINKED TO (B)(4).

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Ecchymosis; Joint Laxity; No Clinical Signs, Symptoms or Conditions; Pain; Swelling/ Edema

  MAUDE report 13154346 ↗
• InjuryDec 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN ASSOCIATED WITH MILD LAXITY. A POLY EXCHANGE WAS PERFORMED SUCCESSFULLY. THERE WAS NO MALROTATION, MALPOSITION, JOINT LINE CHANGE OR POLY WEAR NOTED. NO SURGICAL DELAY. DOI: (B)(6) 2013; DOR: (B)(6) 2021 ; LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 13118097 ↗
• InjuryOct 19, 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: Unspecified Infection

  MAUDE report 12660023 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE AFFECTED SIDE WAS THE RIGHT KNEE.

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

  MAUDE report 12438218 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS PERIPROSTHETIC KNEE INFECTION. NO DELAY IN SURGERY. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 11398548 ↗
• InjurySep 28, 2020Adverse Event Without Identified Device or Use Problem; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. FEMUR INSERTED (B)(6) 2019, INSERT EXCHANGED (B)(6) 2019. FEMUR AND INSERT REMOVED AND CONVERTED TO HINGED PROSTHESES AS MCL WAS FOUND TO BE INCOMPETENT. CEMENT IS IN HOSPITAL INVENTORY SO NO RECORD AVAILABLE. NO SURGICAL DELAY. DOI: (B)(6) 2019 - FEMORAL. DOI: (B)(6) 2019 - INSERT. DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Adhesion(s); Joint Contracture; Joint Laxity; No Code Available; Pain; Swelling/ Edema; Synovitis

  MAUDE report 10595878 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY TKR WHERE A STRYKER KNEE WAS UTILIZED. THIS KNEE WAS LATER REVISED TO A STRYKER REVISION. ON THE (B)(6) 2015 THE STRYKER REVISION KNEE WAS REVISED TO A PFC TC3. PATIENT HAS PRESENTED WITH A PAINFUL AND STIFF KNEE, WITH A LIMITED RANGE OF MOTION. BONE SCANS SHOW AN UPTAKE AROUND THE FEMORAL COMPONENT INDICATING A POSSIBLE LOOSE FEMORAL COMPONENT. A DECISION WAS MADE TO REVISE THE FEMORAL COMPONENT AND BEARING ON (B)(6) 2020. ON OPENING THE KNEE, THE FEMORAL COMPONENT WAS NOT OVERTLY LOOSE AND DID REQUIRE A LITTLE WORK TO REMOVE. IT WAS, HOWEVER CONSIDERED TO BE LOOSE. A DECISION WAS MADE TO CONVERT THE TC3 FEMUR TO AN S ROM HINGED KNEE (ALLOWING MORE MOBILITY) WHILE LEAVING THE REVISION TIBIAL TRAY IN SITU.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 10581860 ↗
• InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD REVISION WITH SIGMA RP TC3 KNEE. THE PATIENT HAD DEVELOPED INSTABILITY AND LAXITY. THERE WAS A 12.5MM TC3 RP INSERT AND THAT WAS EXCHANGED TO A 20MM TP TC3 INSERT. THE KNEE WAS STABLE AND THE SURGEON SEEMED SATISFIED WITH THE RESULT. THERE DID NOT SEEM TO BE VISIBLE DAMAGE OR WEAR TO THE INSERT THAT WAS REMOVED. DOI: 3 TO 4 YEARS AGO, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10476059 ↗
• InjuryAug 3, 2020Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS HEMATOMA EVACUATION, IRRIGATION AND DEBRIDEMENT. I WAS NOT PRESENT AS IMPLANTS WERE PLACED ON CART FOR STAFF TO PULL. THE SURGEON NEEDED THICKER POLY AND STAFF GAVE INCORRECT SIZE 4X17.5 TCB RP POLY. THE PROCEDURE WAS SUCCESSFUL AS SURGEON WAS OK WITH THE MISMATCH. THE KNEE FUNCTIONED WELL AND WELL/STABLE THROUGHOUT RANGE OF MOTION. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10357049 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. I & D WAS DONE. DOI: (B)(6) 2019. DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9539593 ↗
• InjuryNov 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9292738 ↗
• InjuryOct 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS ACUTE INFECTION. SURGEON WASHED OUT THE JOINT AND EXCHANGED POLY. NO FAILURE TO THE IMPLANT THAT WAS EXCHANGED. DOI: UNKNOWN; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9218140 ↗
• InjuryOct 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS A VERY POOR RANGE OF MOTION, 40 DEGREE FROM 30-70 OF FLEXION. THE SURGEON CHOOSES TO REMOVE THE FEMORAL COMPONENTS AND PLACE A HINGED PROSTHESIS. DOI: (B)(6) 2017; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 9202777 ↗
• InjuryJul 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. NO SIGNS OF INFECTION OR INSTABILITY. DOI: (B)(6) 2017; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8812803 ↗
• InjuryDec 5, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 8133645 ↗
• InjuryApr 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT PATIENT'S KNEE WAS REVISED BECAUSE OF KNEE PAIN, DUE TO POSSIBLY CEMENT DISEASE. THE PATIENT INSISTED THAT IT BE REVISED, EVEN THOUGH ALL OF THE COMPONENTS APPEARED TO BE WELL FIXED. ALL OF THE COMPONENTS WERE WELL FIXED. ONLY THE FEMORAL COMPONENT, PATELLA COMPONENT, AND TIBIAL INSERT WERE REPLACED DURING THE REVISION PROCEDURE. THERE DID APPEAR TO BE SOME DELAMINATION OF THE PATELLA COMPONENT UPON EXAMINATION. CEMENT MANUFACTURER UNKNOWN. DOI: UNKNOWN DOR: (B)(6) 2018 RIGHT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7435675 ↗
• InjuryJan 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND REPLACED WITH NEW POLY AFTER WASHOUT. DOI: UNKNOWN; DOR: (B)(6) 2017; LEFT KNEE. NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 7198817 ↗
• InjuryDec 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. SURGEON REMOVED ALL IMPLANTS AND PERFORMED EXTENSIVE I&D AND PLACEMENT OF ANTIBIOTIC CEMENT COATED TIBIAL NAIL FOR TEMPORARY STABILIZATION OF THE KNEE. DOI: (B)(6) 2017, DOR: (B)(6) 2017, RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7141718 ↗
• InjuryAug 29, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6828734 ↗