SIGMA 96-2333Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295242147), received between Sep 26, 2017 and Jun 15, 2026 — classified as 15 injuries.

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. 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION OF KNEE. DOI: UNKNOWN, DOR: ON (B)(6) 2026, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25505353 ↗
• InjuryMar 21, 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 INFLAMMATION. THERE WAS NO PATIENT HARM OR DELAY IN CASE. THE KNEE WAS WASHED OUT AND THE IMPLANT WAS REPLACED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inflammation

  MAUDE report 21662631 ↗
• InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND TORE ARTHROTOMY FROM PREVIOUS REVISION ON (B)(6) 2024. THE DOCTOR DECIDED TO DO A WASH OUT AND POLY SWAP. THERE IS NO SURGICAL DELAY. DOI- (B)(6) 2024; DOR- (B)(6) 2024; AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Fall; Muscle/Tendon Damage; Unspecified Musculoskeletal problem

  MAUDE report 20613219 ↗
• InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO BONY INGROWTH PREVENTING EXTENSION OF THE KNEE. SURGEON REMOVED THE POLY TO CLEAN OUT THE BONY INGROWTH AND REPLACED THE POLY WITH A SMALLER/CR POLY. THERE WAS NO SURGICAL DELAY.

  Patient problems: Loss of Range of Motion; Unspecified Musculoskeletal problem

  MAUDE report 17378138 ↗
• InjuryJul 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD PAINFUL RIGHT TKA REVISION. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17332957 ↗
• InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN; DOE: (B)(6) 2021; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 13174696 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. UNKNOWN BONE CEMENT WAS USED. NO SURGICAL DELAY. DOI: NOT INDICATED/UNKNOWN, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11142664 ↗
• InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2018. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11116551 ↗
• InjuryDec 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAINFUL RIGHT TKA REVISION. DOI: UNKNOWN; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 10938385 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RADIOLOGY REPORT (B)(6) 2017 (POST REVISION SURGERY) REVEALS THE HARDWARE APPEARS TO BE INTACT. THERE IS A REMOTE AVULSION FRACTURE OF THE MEDIAL ASPECT OF THE MEDIAL FEMORAL CONDYLE. THERE IS NO INDICATION OF TREATMENT RELATED TO THIS AVULSION FRACTURE. IT IS UNKNOWN WHEN THIS FRACTURE OCCURRED, DURING THE REMOVAL OF PREVIOUS IMPLANTS OR IMPLANTATION OF REVISION IMPLANTS. THEREFORE, THIS WILL NOT BE CAPTURED AS A SEPARATE EVENT. OFFICE NOTES (B)(6) 2017 ¿ (B)(6) 2020 INDICATE THE PATIENT CONTINUES TO EXPERIENCE PAIN, STIFFNESS, WEAKNESS, INSTABILITY, SWELLING AND LEG LENGTH DISCREPANCY. THE PATIENT ALSO STATES SHE HAS SKIN DISCOLORATION ON THE MEDIAL ASPECT OF HER LOWER LEG. IT IS INDICATED THE SURGEON HAS DISCUSSED THE POTENTIAL NEED FOR FUTURE REVISION, HOWEVER, THERE IS NO INDICATION AN ADDITIONAL REVISION SURGERY HAS TAKEN PLACE. IT IS INDICATED, HOWEVER, THAT THE PATIENT HAS RECEIVED PAIN BLOCK INJECTIONS DUE TO HER KNEE PAIN. A SHOE HEEL LIFT WAS PROVIDED TO HELP ADDRESS THE LEG LENGTH DISCREPANCY. WHOLE BODY BONE SCAN WAS PERFORMED ON (B)(6) 2019 REVEALS LOW-LEVEL ACTIVITY DIFFUSELY AROUND THE LEFT KNEE PROSTHETIC. NO SIGN OF OSTEOMYELITIS OR FRACTURE. DOI: (B)(6) 2016 (PAT

  Patient problems: Fatigue; Joint Laxity; Muscular Rigidity; Pain; Physical Asymmetry; Skin Discoloration; Swelling/ Edema

  MAUDE report 10927384 ↗
• InjuryJun 22, 2020Off-Label Use; Off-Label Use

  THIS PC RELATED TO (B)(4). THE PRIMARY SURGERY WAS PERFORMED ON AN UNKNOWN DATE VIA TKA FOR THE PATIENT¿S RIGHT KNEE JOINT. THE 1ST REVISION SURGERY WAS PERFORMED ON (B)(6) 2015 (THIS EVENT WAS REPORTED AS (B)(4).). THE 2ND REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE TIBIAL TRAY, THE TIBIAL SLEEVE, THE TIBIAL STEM AND THE TIBIAL INSERT (THIS EVENT WAS REPORTED (B)(4)). WHEN THE 2ND REVISION SURGERY, THE SURGEON INSERTED THE TIBIAL INSERT (P/N: 962333, SIZE2.5/15MM) AND THE TIBIAL TRAY (MBT/REV#1.5, P/N: UNKNOWN, SIZE1.5), AND THERE WAS SIZE¿S MISMATCH BETWEEN THE TIBIAL SIDE IMPLANTS AND A FEMORAL COMPONENT (SIZE2.5, P/N: UNKNOWN). THE SURGEON ACCEPTED THIS MISMATCH. IT WAS REPORTED THAT THE 3RD REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE TIBIAL INSERT AND REPAIRING PATELLA TENDON DUE TO RUPTURE OF PATELLA TENDON. THE SURGEON THOUGHT THAT THE TIBIAL INSERT WAS OVERSIZE FOR THE TIBIAL TRAY, AND THIS MIGHT CAUSE THE RUPTURE OF PATELLA TENDON. THEREFORE, THE SURGEON INSERTED A TIBIAL INSERT (SIZE1.5/ 17.5MM THICK, P/N: UNKNOWN) THIS TIME. THE SURGEON ACCEPTED SIZE¿S MISMATCH BETWEEN FEMORAL COMPONENT AND THE TIBIAL INSERT. THE SURGERY WAS COMPLETE

  Patient problems: No Code Available

  MAUDE report 10178609 ↗
• InjuryNov 25, 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) 2017. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9369555 ↗
• InjuryApr 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION TKR; (B)(6) 2018. PRIMARY DATE UNKNOWN; THIS PATIENT HAS AN EXTENSIVE MEDICAL HISTORY WITH HER LEFT KNEE. REVISION: (B)(6) 2018. PATIENT HAS A FIXED FLEXION OF ABOUT 30 DEGREES AND HAS PAIN. THE POLY WAS REMOVED AND A THINNER POLY TO HELP REDUCE THE FLEXION DEFORMITY. THE PATIENT ALSO UNDERWENT A MEDIAL GASTROCNEMIUS TRANSFER TO IMPROVE HER EXTENSOR MECHANISM.

  Patient problems: No Code Available; Not Applicable; Pain

  MAUDE report 7457459 ↗
• InjuryMar 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES SURGEON SAYS PATIENT QUADRICEPS MECHANISM IS DESTROYED AND KNEE INFECTED. A POLY EXCHANGE AND WASH OUT WAS DONE. THE SURGEON HAD A LIMITED PATIENT CONSENT. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7321766 ↗
• InjurySep 26, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT HAD MBT REVISION TC3 LT KNEE. PATIENT IS INFECTED. DEBRIDED AND POLY SWAP.

  Patient problems: Unspecified Infection

  MAUDE report 6895563 ↗