SIGMA 1024-08-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295001799), received between Jul 27, 2017 and Feb 9, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryFeb 9, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR PAIN AND UPON EXTRACTING THE IMPLANTS, THE FEMORAL COMPONENT WAS LOOSE INTERFACE: CEMENT TO IMPLANT, CEMENT MANUFACTURER DEPUY SYNTHES. EXTRACTED ALL UNI IMPLANTS. CONVERTED TO A TOTAL KNEE. NO DELAY IN SURGERY NO INJURY TO PATIENT. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24291800 ↗
• InjuryAug 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT MEDIAL DEPUY HP PARTIAL UNI. INITIALLY PATIENT DID REALLY WELL WITH THIS CONSTRUCT. MORE RECENTLY PATIENT HAS HAD PAIN IN THE KNEE. PATIENT ELECTED TO CONVERT THE UNI TO A TOTAL KNEE. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17434041 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT MEDIAL UKA REVISION FOR PAIN AND OSTEOARTHRITIS. DOI: (B)(6) 2020. DOR: (B)(6) 2023. RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16643208 ↗
• InjuryJun 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A RIGHT REVISION OF THE UNICOMPARTMENTAL KNEE DUE TO PAIN SECONDARY TO LOOSENING. UPON ENTERING THE JOINT, THE FEMORAL COMPONENT WAS GROSSLY LOOSE AT AN UNKNOWN INTERFACE AND EASILY REMOVED. THERE WAS NO REPORTED PRODUCT PROBLEM OF THE EXPLANTED TIBIAL TRAY OR INSERT. THERE WAS NO INDICATION OF INFECTION OR INFLAMMATION IN THE KNEE. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS. THE PATIENT HAD THE POSTOPERATIVE COMPLICATIONS OF ACUTE KIDNEY INJURY, HYPOTENSION, AND ACUTE ANEMIA SECONDARY TO ANESTHETIC MEDICATION IMBALANCE AND DEHYDRATION. THE PATIENT WAS TREATED WITH SUPPLEMENTAL OXYGEN, MEDICATION ADJUSTMENT, AND AGGRESSIVE ORAL AND IV FLUID INTAKE. THE PATIENT DID NOT REQUIRE A PROLONGED HOSPITAL STAY. ON (B)(6) 2018, THE PATIENT REPORTED HEALING NICELY WITH NO FURTHER COMPLICATIONS. THE REVISION PROCEDURE IS CAPTURED ON (B)(4). DOI: (B)(6) 2012 (BILATERAL). DOR: (B)(6) 2018 (RIGHT). DOE: (B)(6) 2018 (RIGHT POSTOPERATIVE AKI AND ANEMIA). DOR: (B)(6) 2019 (LEFT).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; No Code Available; Renal Failure

  MAUDE report 10213473 ↗
• InjuryFeb 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN WITH A UNICONDYLAR PARTIAL KNEE IMPLANT CONVERTED TO A TOTAL KNEE. DOI: (B)(6) 2019. DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9770094 ↗
• InjuryOct 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS TORE PCL. THE DOCTOR REPLACED UNI WITH A POSTERIOR CRUCIAL TOTAL KNEE. DOI: (B)(6) 2018; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9224492 ↗
• InjuryAug 29, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN AFTER RBI WAS IMPLANTED.

  Patient problems: Pain

  MAUDE report 6828449 ↗
• InjuryJul 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 6746750 ↗