SIGMA 1024-53-507Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295002635), received between Nov 19, 2017 and May 7, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Difficult to Insert

  IN THE END SURGERY, THEY TRIED TO INSTALL THE INSERT AND IT DIDN'T GRASP ON THE TRAY AFTER SEVERAL ATTEMPTS. THEY TOOK A NEW INSERT AND ACHIEVED THE SAME RESULT. THEN THEY TOOK A SLIGHTLY HIGHER 1 MM BECAUSE THEY DIDN¿T HAVE MORE IN STOCK. THE SAME RESULT WAS ACHIEVED. THEY STRUGGLED WITH THE FOURTH INSERT AND THEY GOT IT IN PLACE.

  Patient problems: Insufficient Information

  MAUDE report 25112344 ↗
• MalfunctionMay 7, 2026Difficult to Insert

  IN THE END SURGERY, THEY TRIED TO INSTALL THE INSERT AND IT DIDN'T GRASP ON THE TRAY AFTER SEVERAL ATTEMPTS. THEY TOOK A NEW INSERT AND ACHIEVED THE SAME RESULT. THEN THEY TOOK A SLIGHTLY HIGHER 1 MM BECAUSE THEY DIDN¿T HAVE MORE IN STOCK. THE SAME RESULT WAS ACHIEVED. THEY STRUGGLED WITH THE FOURTH INSERT AND THEY GOT IT IN PLACE.

  Patient problems: Insufficient Information

  MAUDE report 25112343 ↗
• InjuryMar 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DEPUY CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2013. DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11444299 ↗
• MalfunctionApr 25, 2018Fitting Problem; Fitting Problem

  DER STATES THAT THE SURGEON HAD STRUGGLES WITH IMPLANTING THE ORIGINAL POLY. HE REMOVED SOME ADDITIONAL SOFT TISSUES THAT MAY BE CAUSING THE ISSUE AND CONTINUED TO TRY TO INSERT THE POLY. HE ASKED FOR A SECOND POLY WHEN THE ORIGINAL HAD GOTTEN BEAT UP A LITTLE IN THE IMPLANT PROCESS. THE SECOND POLY SEEMED TO SNAP IN WITH NO PROBLEMS AT ALL. THE SURGEON WAS PLEASED WITH THE FINAL PRODUCT AND BEGAN THE CLOSING PROCESS. DOE: (B)(6) 2018; LEFT KNEE.

  Patient problems: No Known Impact Or Consequence To Patient; Not Applicable

  MAUDE report 7457549 ↗
• MalfunctionJan 5, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DER STATES THAT AFTER HOLDING THE LEG IN EXTENSION WHILE THE CEMENT CURED, SURGEON CONFIRMED THAT THE REQUIRED POLY WAS A SZ 5, 7MM INSERT FOR A METAL BACKED TIBIA. THE COMPONENT DIDN'T SEEM TO ENGAGE INTO THE TIBIA AFTER A FEW ATTEMPTS, SO SURGEON REQUESTED THAT I OPEN A SECOND POLY TO IMPLANT. SURGERY TIME WAS EXTENDED FOR 15-20 MINUTES. DOE: (B)(6) 2017; LEFT HIP.

  Patient problems: Not Applicable

  MAUDE report 7167562 ↗
• MalfunctionNov 19, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SURGEON DID A SIGMA HP UNI ON THIS PATIENT AND COULD NOT GET THE POLY TO LOCK INTO THE TRAY AFTER SEVERAL ATTEMPTS. ANOTHER POLY WAS OPENED AND LOCKED INTO PLACE IMMEDIATELY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7044232 ↗