SIGMA 1024-51-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295002338), received between Nov 2, 2017 and Aug 6, 2026 — classified as 13 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (3 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50168263 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT REPORTS THAT ON (B)(6) 2025 HE UNDERWENT A 1.5T LIVER MRI. THE PATIENT HAS A LEFT KNEE PROSTHESIS IMPLANTED ON (B)(6) 2025. DURING THE EXAMINATION, THE PATIENT REPORTS INITIALLY FEELING WARMTH, WHICH PROGRESSIVELY INTENSIFIED, REACHING ALMOST UNBEARABLE HEAT IN THE LOWER PART OF THE PATELLA OF THE LEFT KNEE (WHERE THE PROSTHESIS IS IMPLANTED). HE DOES NOT RECALL WHETHER THERE WAS REDNESS AT THE LEVEL OF THE KNEE. AFTER THE EXAMINATION, THE PATIENT CONTINUED TO EXPERIENCE SEVERE PAIN, UNTIL ON (B)(6) 2025 IT WAS DECIDED TO REPLACE THE PROSTHESIS WITH A NEW ONE (THE SURGERY WAS PERFORMED AT AN INSTITUTE DIFFERENT FROM HOSPITAL, THEREFORE WE DO NOT HAVE FURTHER DETAILS). THE DEVICE CARDS WERE REQUESTED (ATTACHED TO THE REPORT), AND BOTH ARE INDICATED BY THE COMPANY AS MRI SAFE. THE PROSTHESIS CONSISTS OF 3 COMPONENTS; ALL INDICATED ON THE ATTACHED LABELS.

  Patient problems: Inflammation; Pain

  MAUDE report 24483909 ↗
• 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 21047632 ↗
• InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SUFFERING FROM INFLAMMATION, BRUSHING, LACK OF MOTION AFTER A PARTIAL KNEE REPLACEMENT. DOI: (B)(6) 2022 DOE: JUN, 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inflammation; Loss of Range of Motion; Pain

  MAUDE report 19331674 ↗
• 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 17511813 ↗
• InjuryDec 6, 2022Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  TOTAL KNEE REVISION OF A FAILED LEFT MEDIAL UNI KNEE REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 15925918 ↗
• InjurySep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY LM UNICOMPARTMENTAL KNEE SURGERY ON (B)(6) 2020 WHEN A SIGMA PARTIAL KNEE WAS UTILIZED (DR (B)(6), (B)(6) PRIVATE). PATIENT PRESENTED WITH A PAINFUL KNEE AND THE TIBIAL COMPONENT WAS REVISED ON (B)(6) 2021 (DR (B)(6), (B)(6) HOSPITAL) (SEE (B)(4)). PATIENT INITIALLY DID WELL AND PRESENTED AGAIN WITH A PAINFUL KNEE - THIS RESULTED ON A POLY EXCHANGE OF THE TIBIAL COMPONENT AND A WASHOUT ON (B)(6) 2021 (DR (B)(6) , (B)(6)) (SEE PC (B)(6)). PATIENT WAS THEN DOING WELL UNTIL APPROXIMATELY 6 MONTHS AGO WHEN HE STARTED TO EXPERIENCE A PAINFUL KNEE. A DECISION WAS MADE TO REVISE THE SIGMA PARTIAL TO A TOTAL KNEE WITH A STEM AND SLEEVED TIBIA. ON OPENING THE KNEE ((B)(6) 2022, DR (B)(6), (B)(6) HOSPITAL) THE TIBIAL COMPONENT WAS FOUND TO BE LOOSE - WITH THE FAILURE AT THE BONE CEMENT/ BONE INTERFACE. ALL COMPONENTS WERE REMOVED AND STEMMED AND SLEEVED ATTUNE REVISION TIBIAL COMPONENT IMPLANTED ALONG WITH A PRIMARY PS FEMORAL COMPONENT. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? UNKNOWN. IF YES, PLEASE DESCRIBE. LOOSE TIBIAL COMPONENT - REVISION TO TOTAL KNEE. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION,

  Patient problems: Pain; Unspecified Infection

  MAUDE report 15485752 ↗
• 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 11831697 ↗
• 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

  MEDICAL RECORDS REVIEWED. ON (B)(6) 2016, PATIENT RECEIVED A MEDIAL LEFT KNEE UNICOMPARTMENTAL ARTHROPLASTY, TO ADDRESS MEDIAL COMPARTMENT OSTEOARTHRITIS. THERE WAS NO REPORTED COMPLICATION. ON (B)(6) 2018, PATIENT'S LEFT KNEE WAS REVISED TO ADDRESS PAIN AND SUSPECTED IMPLANT LOOSENING. IT WAS DETERMINED THOUGH, THAT THERE WAS NO IMPLANT LOOSENING--BOTH FEMUR AND TIBIAL TRAY COMPONENTS WERE WELL-FIXED. RATHER, IT WAS IDENTIFIED THAT THE TIBIAL INSERT COMPONENT LOCKING MECHANISM HAD PARTIALLY FAILED, WITH THE INSERT MOVING IN THE TRAY. THIS INSERT COMPONENT WAS REVISED, AND SCAR TISSUE EXCISED.

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

  MAUDE report 9221439 ↗
• 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 9119072 ↗
• InjuryAug 26, 2019Malposition of Device; Unintended Movement; Malposition of Device; Unintended Movement

  THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO A MEDIAL TIBIAL CONDYLE FRACTURE WITH TIBIAL TRAY SUBSIDENCE AND MALPOSITIONING. THE SURGEON NOTED THERE WAS NO LOOSENING. DEPUY CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2016 . DOR: 8/1/2016 LEFT KNEE.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 8929954 ↗
• InjuryDec 18, 2018Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE PATIENT'S POLY DISLOCATED.

  Patient problems: No Code Available

  MAUDE report 8174367 ↗
• InjuryJul 27, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  THE FOLLOWING SIGMA PARTIAL IMPLANTS WERE REMOVED TODAY DURING REVISION SURGERY BY MR (B)(6): 102451300, LOT H04614 SIZE 3 TRAY LM; 102407400, LOT C43498 SIZE 4 FEMUR LM; 102453308, LOT C55541 SIZE 3 8MM LM. ORIGINAL SURGERY: (B)(6) 2017. THE SURGEON SAID THAT AN INTRAOPERATIVE TIBIAL FRACTURE AND SUBSEQUENT SUBSIDENCE OF THE TIBIAL COMPONENT WAS THE CAUSE FOR REVISION NO FOLLOW UP INFORMATION REQUESTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 7727718 ↗
• InjuryFeb 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION UNI KNEE REPLACEMENT , DR (B)(6) - (B)(6) ON (B)(6) 2018. PRIMARY IMPLANT DATE: (B)(6) 2017. PATIENT PRESENTED TO SURGEON WITH KNEE PAIN. ON X-RAY EXAMINATION IT WAS NOTED THAT A TIBIAL FRACTURE NOTED BELOW THE IMPLANT. A REVISION KNEE REPLACEMENT WAS PERFORMED AND A REVISION TOTAL KNEE WAS INSERTED. FEMALE (B)(6). NO SUPPORTING DOCUMENTATION AVAILABLE

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 7295705 ↗
• InjuryJan 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION OF UNI KNEE; DR (B)(6), (B)(6) HOSPITAL 11.12.2017. 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: (B)(6), AGED: (B)(6) YEARS, DOB: (B)(6)1934.

  Patient problems: Pain

  MAUDE report 7171187 ↗
• InjuryNov 2, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  PATIENT WAS REVISED TO ADDRESS TIBIAL SUBSIDENCE, PAIN AND LAXITY. IT WAS ALSO REPORTED THAT THE PATIENT HAD ALSO DEVELOPED SOME PATELLA FEMORAL ARTHRITIS.

  Patient problems: Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 6998239 ↗