SIGMA 97-0451Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295250555), received between Oct 18, 2017 and Nov 4, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  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 PAIN AND HYPEREXTENSION DEFORMITY. TIBIAL INSERT SHOWED MODERATE YELLOWING.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 23468049 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN WITH SIGNS OF INSTABILITY AFTER KNEE SURGERY ON AN UNKNOWN DATE. SURGEON REMOVED THE 10MM POLY, TRIALED A 12.5 MM, AND FINALLY INSERTED A 12.5MM INSERT. NO DISCUSSIONS OF ISSUES WITH IMPLANTS OF ISSUES OF MANUFACTURE WERE MENTIONED. AFFECTED SIDE: LEFT SIDE.

  Patient problems: Joint Laxity

  MAUDE report 22829380 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18013108 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A WASHOUT FOR INFECTION AND POLY WAS EXCHANGED. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17834178 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INFECTED KNEE. SURGEON WENT BACK IN AND DID AN I&D. KNEE WAS STABLE SO INSERT WAS REMOVED AND THE SAME SIZE INSERT WAS IMPLANTED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17237418 ↗
• InjuryJun 20, 2022Noise, Audible; Noise, Audible

  IT WAS REPORTED BY THE PATIENT THAT HE IS CURRENTLY IN THE WEBSITE FOR A DEPUY KNEE RECALL AND HE IS HOPING IF SOMEONE HE CAN SPEAK WITH.

  Patient problems: Ambulation or Postural Difficulties; Cramp(s) /Muscle Spasm(s); Erythema; Fatigue; Hemorrhage/Blood Loss/Bleeding; Inflammation; Loss of Range of Motion; Nerve Damage; Pain; Swelling/ Edema

  MAUDE report 14743933 ↗
• InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12565222 ↗
• InjuryDec 11, 2020Naturally Worn; Naturally Worn

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS COLLAPSED MEDIAL AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. THE POLY AND TIBIAL TRAY WERE REMOVED. AFTER EXAMINING THE POLY THE DOCTOR ASK FOR THE POLY TO BE EXAMINED BY DEPUY FOR UNUSUAL WEAR PATTERNS AND DEFICIENCIES FOR ONLY HAVING BEEN IMPLANTED FOR 2 YEARS. DOI: (B)(6) 2018, DOR: (B)(6) 2020, UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 10991690 ↗
• InjurySep 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT SHE HAD A TOTAL KNEE REPLACEMENT AND SCHEDULED FOR ARTHROSCOPIC SURGERY ON (B)(6), TO SEE OF THERE IS ANYTHING THAT CAN BE DONE TO EASE THE PAIN AND IMPROVE HER RANGE OF MOTION, WHICH IS ONLY 90 DEGREES AND POSSIBLE ALLERGY TO NICKLE. THE CUSTOMER ALSO MENTIONED THAT SHE MADE A CONTACT THROUGH EMAIL ABOUT THREE TIMES BUT RECEIVED NO RESPONSE. DOI: (B)(6) 2019. DOR: NONE REPORTED; (UNK KNEE).

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

  MAUDE report 10600959 ↗
• InjurySep 16, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  ON (B)(6) 2018, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN, ARTHROFIBROSIS, ADHESIONS, SCARRING, STIFFNESS, AND DECREASED RANGE OF MOTION. THE TIBIAL INSERT WAS THE ONLY PRODUCT REVISED. DOI: (B)(6) 2015; DOR: (B)(6) 2018, RIGHT KNEE.

  Patient problems: Adhesion(s); Fibrosis; Loss of Range of Motion; No Code Available; Pain; Scarring

  MAUDE report 9071018 ↗
• InjuryJan 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL KNEE DUE TO A SNAPPING IT BAN. IT ALSO STATED A POLY EXCHANGE WAS PERFORMED. DOI: (B)(6) 2017; DOR: (B)(6) 2017; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 7164143 ↗
• InjuryOct 18, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT CHIEF COMPLAINT WAS PAIN. SURGEON WENT IN AND RELEASED SOME SOFT TISSUE ON THE LATERAL SIDE. HE ALSO CHANGED THE INSERT FROM A SIZE 3 X 10MM CURVED PLUS SIGMA POLY TO A SIZE 3 X 12.5MM CURVED PLUS POLY. THE FEMORAL, TIBIAL AND PATELLA COMPONENTS WERE WELL FIXED AND POSITIONED AND RETAINED.

  Patient problems: Pain

  MAUDE report 6959583 ↗