SIGMA 1024-53-307Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295002536), received between Jan 8, 2018 and Dec 31, 2024 — classified as 7 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2024Difficult to Insert; Device Damaged Prior to Use; Difficult to Insert; Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING THE SURGERY, THE SPACER WAS FOUND TO BE DEFORMED, AND THE UNICOMPARTMENTAL TIBIAL PLATEAU DID NOT MATCH THE SPACER. CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21047615 ↗
• MalfunctionAug 11, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING THE SURGERY, IT WAS FOUND THAT THE INSERT COULD NOT BE LOCKED AND IT WAS EASY TO LOOSEN AND PULL OUT. REPLACING THE INSERT CAUSED THAT THE PROCEDURE DELAYED BY APPROXIMATELY 30 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 17513385 ↗
• MalfunctionAug 11, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING THE SURGERY, IT WAS FOUND THAT THE INSERT COULD NOT BE LOCKED AND IT WAS EASY TO LOOSEN AND PULL OUT. REPLACING THE INSERT CAUSED THAT THE PROCEDURE DELAYED BY APPROXIMATELY 30 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 17511809 ↗
• InjuryNov 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY. THE AFFECTED SIDE WAS THE LEFT SIDE.

  Patient problems: Extraskeletal ossification; Unspecified Musculoskeletal problem

  MAUDE report 12751616 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY RIGHT LATERAL UNICOMPARTMENTAL KNEE REPLACEMENT ON (B)(6) 2008 WHERE A SIGMA PARTIAL WAS UTILISED. PATIENT HAS PRESENTED WITH A PROGRESSIVELY MORE PAINFUL KNEE AND HAS REPORTED FEELINGS OF INSTABILITY ON THE LATERAL SIDE. ON OPENING THE KNEE ((B)(6) 2021 (B)(6)) ALL COMPONENTS WERE FOUND TO BE WELL FIXED. REASON FOR REVISION WAS PROGRESSION OF DISEASE AND PAIN. COMPONENTS WERE REMOVED AND A RIGHT PRIMARY ATTUNE PS RP IMPLANTED.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11831682 ↗
• InjurySep 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. POLY EXCHANGE PERFORMED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10523440 ↗
• InjuryOct 22, 2019Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  THE ANTERIOR LIP OF POLY JUST LIFTED UP 1-2MM.

  Patient problems: Adhesion(s); Discomfort; No Code Available; Pain

  MAUDE report 9221438 ↗
• MalfunctionSep 25, 2019Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE FINAL POLY WOULD NOT ALIGN ON BOTH SIDES OF TRAY TO BE SNAPPED INTO PLACE. TRIED FOR 90 MINUTES TO NO AVAIL. SURGEON REMOVED WELL FIXED METAL BACK TIBIA AND CEMENTED IN ALL POLY.

  Patient problems: Not Applicable

  MAUDE report 9119069 ↗
• InjuryDec 18, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S POLY DISLOCATED.

  Patient problems: No Code Available

  MAUDE report 8174412 ↗
• InjuryJun 19, 2018Disassembly; Disassembly

  DER STATES PATIENT HAD PAIN SO SURGEON OPENED UP THE PATIENT'S KNEE AND SAW THAT THE POLY WAS LOOSE. SO HE REMOVED AND IMPLANTED IN A NEW POLY BEARING. DOI: (B)(6) 2017. DOR: (B)(6) 2018. LEFT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7613464 ↗
• InjuryJan 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION OF UNI KNEE; DR (B)(6) , (B)(6) PRIVATE HOSPITAL, (B)(6) 2017. PATIENT UNDERWENT PRIMARY UNICONDYLAR KNEE REPLACEMENT ON (B)(6) 2014 (DR (B)(6), (B)(6) HOSPITAL). PATIENT HAS DONE WELL UNTIL 3 MONTHS AGO WHEN THE KNEE BECAME PAINFUL, ESPECIALLY WHEN ROLLING OVER IN BED AT NIGHT. ON REVIEWING THE X RAYS IT WAS SUSPECTED THAT THE TIBIAL TRAY MAY BE LOOSE. ON OPENING THE JOINT, THE TRAY APPEARED TO BE WELL FIXED, WITH NO OBVIOUS ISSUES (WEAR, LOOSE COMPONENTS ETC). THE UNI KNEE WAS REMOVED AND A PFC TC3 RP IMPLANTED. FEMALE PATIENT INITIALS EC, AGED (B)(6) YEARS, DOB (B)(6).

  Patient problems: Pain

  MAUDE report 7171223 ↗