SIGMA 1024-12-208Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295002116), received between Feb 5, 2019 and Mar 20, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR PAINFUL KNEE. UNI WAS LATERAL. PATIENT HAD MEDIAL WEAR AND PATELLA WEAR. NO DELAY. DOI- (B)(6) 2020. DOR- (B)(6) 2024. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Pain

  MAUDE report 18940179 ↗
• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY OPERATIVE NOTES (B)(6) 2016 INDICATE THE PATIENT RECEIVED A RIGHT UNI KNEE REPLACEMENT DUE TO MEDIAL COMPARTMENT OSTEOARTHRITIS AND HISTORY OF ACL INJURY. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. OFFICE NOTES (B)(6) 2018 INDICATE THE PATIENT IS EXPERIENCING INCREASING PAIN AND DIFFICULTY WITH AMBULATING. RADIOGRAPHS REVEAL A SOMEWHAT FLEXED POSITIONING OF THE FEMORAL COMPONENT AND ANTERIOR TRANSLATION OF THE TIBIAL COMPONENT, LATERAL COMPARTMENT OSTEOARTHRITIS IS ALSO PRESENT. REVISION OPERATIVE NOTES (B)(6) 2018 INDICATE THE PATIENT RECEIVED A CONVERSION TO RIGHT TOTAL KNEE ARTHROPLASTY DUE TO PAIN AND POSTERIOR CRUCIATE LIGAMENT RUPTURE. UPON ENTERING THE KNEE, IT WAS NOTED THAT BOTH COMPONENTS WERE NOT WORN, IN GOOD POSITION AND NOT LOOSE. THE KNEE ITSELF WAS NOTED TO BE UNSTABLE POSTERIORLY. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2016. DOR: (B)(6) 2018, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9911686 ↗
• InjuryMar 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A RUPTURED POSTERIOR CRUCIATE LIGAMENT, DATE OF IMPLANTATION: (B)(6) 2016. DATE OF REVISION: (B)(6) 2018 (RIGHT KNEE).

  Patient problems: Ambulation or Postural Difficulties; Joint Disorder; No Code Available; Pain

  MAUDE report 9808285 ↗
• InjuryFeb 5, 2019Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO PAIN AND STIFFNESS. CONVERSION FROM UNI TO TKA. DOI: (B)(6) 2016. DOE:(B)(6) 2018 (RIGHT KNEE).

  Patient problems: Joint Disorder; No Code Available; Pain

  MAUDE report 8304392 ↗

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