SIGMA 1960-30-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295074953), received between Sep 26, 2019 and Mar 15, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PATIENT COMPLAINTS OF PAIN AND A LACK OF MOTION, ASEPTIC LOOSENING OF THE TIBIA WAS SUSPECTED AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 16548090 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN, LACK OF MOTION AND ASEPTIC LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 16453151 ↗
• 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: Hypersensitivity/Allergic reaction; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 10600980 ↗
• InjurySep 26, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 06 SEPTEMBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2013, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. IT WAS NOTED THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS AND PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND SMARTSET BONE CEMENT X 2. ON (B)(6) 2013, THE PATIENT UNDERWENT A RIGHT KNEE MANIPULATION DUE TO STIFFNESS. THE SURGEON INDICATED PALPABLE LYSIS OF ADHESIONS WERE FELT. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2014, THE PATIENT UNDERWENT A RIGHT KNEE ARTHROSCOPY WITH RESECTION OF SCAR TISSUE. DUE TO PAIN. THE SURGEON REPORTED THE SCAR TISSUE WAS REMOVED, AND NO INTEROPERATIVE COMPLICATIONS. ON (B)(6) 2016, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO LOOSENING AND ARTHROFIBROSIS. THE SURGEON NOTED THE FEMORAL COMPONENT WAS NOT GROSSLY LOOSE BUT REMOVED VERY EASILY, AND THE TIBIAL COMPONENT DIS-IMPACTED RATHER EASILY. THE SURGEON DID NOT REPORT WHICH INTERFACES HE FOUND LOOSENING. THE PATELLA WAS REVISED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. UN

  Patient problems: Adhesion(s); Fibrosis; Muscular Rigidity; No Code Available; Pain

  MAUDE report 9125650 ↗