SIGMA 1024-54-507Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295002932), received between Nov 21, 2017 and Feb 18, 2026 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Difficult to Insert

  IT WAS REPORTED THAT THE SIGMA UNI INSERT FAILED INSERTION AND CONSEQUENTLY DAMAGED INSERT WHICH REQUIRED A SECOND INSERT TO BE OPENED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377897 ↗
• InjuryJul 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  "VOLUNTARY REPORT RECEIVED (MW5119018) AND PRODUCT: DEPUY SIGMA UKA PARTIAL KNEE BEARING (MEDICAL DEVICE FAILED TWICE). ON 6/13/23, COMPLAINT RECEIVED FROM (B)(6), EXCERPTED: "COMPLAINANT STATED THE SURGERIES OCCURRED AT (B)(6) ORTHOPEDIC SURGERY, (B)(6) WHICH DR. (B)(6) OPERATED. COMPLAINANT REPORTED HE HAD ONE PARTIAL KNEE SURGERY AND A SECOND ONE THAT WAS AN EMERGENCY REVISION OF THE FIRST SURGERY. COMPLAINANT STATED ONE OF THE KNEE RECONSTRUCTIONS FAILED IN (B)(6) 2020 WHILE HE WAS CLIMBING STAIRS AT A STATE WRESTLING TOURNAMENT. COMPLAINANT STATED THE POLYURETHANE CAME OUT OF PLACE. COMPLAINANT STATED HE HAS A PARTIAL KNEE REPLACEMENT CONDUCTED TO SAVE THE KNEE REPLACEMENT. WHEN THE KNEE REPLACEMENT FAILED A SECOND TIME, HIS DOCTOR RECOMMENDED HE OBTAIN A SECOND OPINION OR OBTAIN ANOTHER SECOND FULL KNEE REPLACEMENT. COMPLAINANT STATED HE OBTAINED A SECOND OPINION FROM DR. (B)(6). DR. (B)(6) INFORMED HIM THAT HE WOULD NOT PERFORM A KNEE REPLACEMENT SURGERY AFTER ANOTHER DOCTOR HAD PREVIOUSLY CONDUCTED SURGERY THE FIRST TIME. DR. (B)(6) INFORMED THE COMPLAINANT HE WOULD PERFORM THE FULL KNEE REPLACEMENT SURGERY WITH THE ASSISTANCE BY DR. (B)(6)." THE COMPLAINANT STATED ONE OF T

  Patient problems: Insufficient Information

  MAUDE report 17390527 ↗
• InjuryMar 23, 2023Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT HAD A RIGHT PARTIAL KNEE REPLACEMENT. ON (B)(6) 2019 THE PATIENT HAD A RIGHT PARTIAL KNEE REVISION. THE PATIENT REPORTS PAIN, AND IT WAS NOTED THAT THERE WERE TWO DISLODGEMENTS OF THE INSERT. IT SHOULD BE NOTED THAT THE THERE WERE NO TIME FRAMES LISTED FOR THE PATIENT HARMS. THERE WAS ALSO NO MENTION OF MANUFACTURER OF IMPLANTS. RADIOGRAPHS FROM 04/01/2019, WE WERE REPORTED TO SHOW A PARTIAL KNEE ARTHROPLASTY WITH WHAT APPEARS TO BE A DISLODGED POLYETHYLENE AND THERE IS ALSO LATERAL PATELLAR TRACKING AND LATERAL PATELLAR TILT. ¿THERE APPEARS TO BE AN UNDERSIZED TIBIAL COMPONENT¿.

  Patient problems: Insufficient Information; Joint Laxity; Pain

  MAUDE report 16597882 ↗
• MalfunctionDec 16, 2021Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE AFFECTED SIDE INVOLVED IN THIS EVENT WAS THE RIGHT KNEE MEDIAL SIDE RM.

  Patient problems: Insufficient Information

  MAUDE report 13017603 ↗
• InjurySep 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. POLY EXCHANGE DONE. NO FURTHER INFORMATION AVAILABLE. DOI: UNKNOWN; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9072116 ↗
• MalfunctionAug 16, 2018Defective Component; Defective Component

  IT WAS REPORTED THAT THE POLY WOULD NOT SEAT INTO THE TIBIAL TRAY AND APPEARED TO BE DEFECTIVE. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7788455 ↗
• MalfunctionDec 5, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DER STATES THAT THE SURGEON COULDN'T SEAT THE INSERT. OPENED A SECOND INSERT, SEATED NEXT TIME WITH NO ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7083806 ↗
• MalfunctionNov 21, 2017Misconnection; Misconnection

  IT WAS REPORTED THAT THE POLY INSERT WOULD NOT ENGAGED INTO TIBIAL TRAY. SURGEON INSPECTED BOTTOM OF POLY AND FELT THAT IT MAY BE DEFECTIVE. SURGICAL DELAY BY 2 MINUTES.

  Patient problems: No Information

  MAUDE report 7048829 ↗