SIGMA 96-2344Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295242253), received between Nov 17, 2017 and Mar 6, 2026 — classified as 24 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INJURED WHILE PLAYING PICKLEBALL, MAKING THE ORIGINAL CONSTRUCT UNSTABLE. IT WAS STATED THAT THE LOOSENING OF TIBIA/FEMUR WAS UNKNOWN. DOI: (B)(6) 2019. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24533476 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. DARTHMOUTH 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 ARTHROFIBROSIS. FEMORAL COMPONENT HAD MINOR CORROSION.

  Patient problems: Arthrofibrosis

  MAUDE report 23465537 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: PLEASE CONFIRM WHAT IMPLANTS WERE MISPOSITIONED. ¿ FEMORAL COMPONENT AND TIBIAL TRAY. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? NO, DUE TO THE MISPOSITIONING OF THE IMPLANTS. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? NO WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO, ALL CORRECT SIZING. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO, REPORTED AS OKAY. WAS THERE A SURGICAL DELAY BECAUSE OF THIS EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? NO.

  Patient problems: Joint Laxity

  MAUDE report 19261606 ↗
• InjuryNov 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS NO LONGER STABLE IN MID-FLEXION, A THICKER INSERT WAS NECESSARY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18148311 ↗
• InjuryMay 16, 2023Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT COMES IN TODAY FOR FURTHER DISCUSSION REGARDING PAINFUL BILATERAL TOTAL KNEE ARTHROPLASTIES. THE PATIENT HAD A RIGHT TOTAL KNEE IN 2006 AND REVISION IN 2019. SHE HAD A LEFT TOTAL KNEE IN 2006, A REVISION IN 2019 AND A SCOPE DEBRIDEMENT IN 2020. THE PATIENT CONTINUES TO HAVE ONGOING PAIN AND DISCOMFORT IN BOTH OF THE KNEES. THE PAIN IS DAILY. IT IS STARTING TO LIMIT HER ACTIVITIES. SHE HAS GOOD RANGE OF MOTION. SHE HAS SOME SWELLING AT TIMES. SHE HAS SOME GRINDING AND POPPING IN BOTH KNEES. THE LEFT KNEE HURTS MORE OFTEN THAN THE RIGHT KNEE. SHE DID PREVIOUSLY DISCUSSED REVISION SURGERY WITH DOCTOR. SHE WOULD LIKE TO PROCEED WITH STAGED TKA REVISIONS, LEFT ONE FIRST. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Discomfort; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 16940747 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND POOR MOTION. POLY EXCHANGE WAS DONE. DOI: UNKNOWN . DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 16888635 ↗
• InjuryDec 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON WASHED OUT THE INFECTED KNEE AND CHANGED THE POLY. NO SURGICAL DELAY WAS THERE. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16004946 ↗
• InjuryAug 9, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO INSTABILITY. A THICKER POLY WAS INSERTED. DOI: (B)(6) 2010, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15191922 ↗
• InjuryFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PATIENT COMPLAINTS OF PAIN AND INSTABILITY. IN SURGERY SURGEON FOUND FEMUR TO BE LOOSE, BUT TIBIA SOLID. A HINGED FEMUR ALONG WITH SLEEVE AND STEM AND THICKER POLY WAS IMPLANTED. DOI: UNKNOWN, DOR: (B)(6) 2022, RIGHT FEMUR.

  Patient problems: Joint Laxity; Pain

  MAUDE report 13446153 ↗
• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. THE KNEE WAS WASHED OUT AND A NEW, THICKER 20MM INSERT WAS PLACED. DOI: (B)(6) 2017. DOR: (B)(6) 2022; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13290195 ↗
• InjuryJul 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND POSSIBLE INFECTION. WASHOUT AND DEBRIDEMENT WAS DONE. NO INDICATION OF INSTABILITY. DOI: (B)(6) 2016 DOR: (B)(6) 2021 LEFT KNEE.

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

  MAUDE report 12150024 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS SIGNIFICANT FLEXION CONTRACTURE BUT INSTABILITY IN FLEXION. TIBIAL COMPONENTS REMOVED ALONG WITH FEMORAL COMPONENTS AND CONVERTED TO DISTAL FEMORAL REPLACEMENT ON EXISTING FEMORAL SLEEVE AND STEM. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2018. DOR: (B)(6) 2021; RIGHT KNEE.

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

  MAUDE report 11554930 ↗
• InjuryJan 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. I&D AND POLY EXCHANGE WAS DONE. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2017 DOR: (B)(6) 2021 LEFT KNEE.

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

  MAUDE report 11251717 ↗
• InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE WAS TIGHT IN FLEXION AND EXTENSION. SURGEON CHANGED THE BEARING FROM A 17.5 TO A 15 MM. DOI: UNKNOWN DOR: (B)(6) 2020 RIGHT KNEE.

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

  MAUDE report 10836595 ↗
• InjuryOct 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10712649 ↗
• InjuryMar 25, 2020Off-Label Use; Off-Label Use

  THE PATIENT WAS REVISED DUE TO THE INSERT WAS UNDERSIZED. A SIZE 4 INSERT SHOULD HAVE BEEN USED TO MATCH THE FEMORAL COMPONENT, NOT A SIZE 3 TO MATCH THE TIBIAL TRAY. CULTURE SHOWED POSITIVE FOR CONSISTENT INFLAMMATION. NO LOOSENING REPORTED. DOI: (B)(6) 2017; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Inflammation; No Code Available

  MAUDE report 9881055 ↗
• InjuryDec 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORD REPORTS PATIENT'S FOLLOW UP NOTES FOR HER ENCOUNTER WITH PHYSICIAN ON 23-JAN-2018 AS REPORTS OF ONGOING PAIN (WHEN ATTEMPTING TO STAND) POST REVISION OF RIGHT TOTAL KNEE ARTHROPLASTY (DOR (B)(6) 2017). RADIOGRAPHIC IMAGES GIVE NO INDICATION OF IMPLANT DEFECTS. PATIENT HAD SEEN A PAIN SPECIALIST AND RECEIVED A RADIOFREQUENCY ABLATION WITHOUT BENEFITS. PHYSICIAN'S DECISION WAS FOR PATIENT TO CONTINUE THERAPY AND FURTHER FOLLOW UPS WITH X-RAYS.

  Patient problems: No Code Available; Pain

  MAUDE report 9511490 ↗
• InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO GENERALIZED KNEE PAIN. POLY EXCHANGE WAS DONE. DOI: (B)(6) 2018; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9458723 ↗
• InjurySep 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. A NEW POLYETHYLENE WAS IMPLANTED. DOI: (B)(6) 2018, DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9039578 ↗
• InjuryMar 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. POLY SWAP WAS PERFORMED. DOI: (B)(6) 2018; DOR: (B)(6) 2019; UNKNOWN AFFECTED SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 8412990 ↗
• MalfunctionJan 15, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT SURGEON IMPLANTED A PS FEMUR AND TC3 INSERT. DISCOVERED THE INCOMPATIBILITY ISSUE POST OP DAY ONE. CONTACTED THE SURGEON IMMEDIATELY AFTER IT WAS DISCOVERED. HE WAS NOT CONCERNED BECAUSE OF HOW THE IMPLANTS FELT DURING TRIALING. BROUGHT THE EXACT SIZE DNI'S OF THE FEMUR AND TC3 INSERT TO SHOW SURGEON TWO DAYS POST OP. SURGEON EXPRESSED HE IS NOT CONCERNED AND ELECTED TO TAKE NO ACTION AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8249838 ↗
• InjuryNov 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY.

  Patient problems: No Code Available; Pain

  MAUDE report 8074140 ↗
• InjuryMar 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS TO INFECTION. DOI: (B)(6) 2018; DOR: (B)(6) 2018. RIGHT KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7366990 ↗
• InjuryFeb 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7298854 ↗
• InjuryNov 17, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. IT ALSO REPORTED THAT THEY DID POLY SWAP I&D.

  Patient problems: Unspecified Infection

  MAUDE report 7040720 ↗