SIGMA 1024-12-308Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295002154), received between Jun 30, 2020 and Jun 30, 2020 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K061648, K070849, K233980); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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: 20 NOV 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 10213478 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061648, K070849, K233980. One submission often covers many models, so check the product and lot details in each record.

• Z-1219-2018 · Dec 21, 2017 · Terminated
  (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GT