U2 Femoral component, CR, porous coated 2103-1230Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04712602345446), received between May 21, 2026 and Jun 25, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2026Osseointegration Problem

  A COMPLAINT CASE REGARDING THE FEMORAL COMPONENT WAS RECEIVED BY THE FRENCH BRANCH ON 2026/05/29. A 76-YEAR-OLD FEMALE PATIENT UNDERWENT TKA SURGERY USING THE U2 TOTAL KNEE SYSTEM ON (B)(6) 2023. THE PATIENT WAS ADMITTED FOR SURGICAL TREATMENT OF A TIBIAL FRACTURE RESULTING FROM A FALL. HOWEVER, AS A PRECAUTIONARY MEASURE, THE ASSESSMENT REVEALED A LACK OF OSSEOINTEGRATION OF THE FEMORAL COMPONENT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2026.

  Patient problems: Insufficient Information

  MAUDE report 25631336 ↗
• InjuryMay 21, 2026Insufficient Device Problem Information

  A COMPLAINT CASE REGARDING THE FEMORAL COMPONENT WAS RECEIVED BY THE FRANCE BRANCH ON 2026/04/21. A 65-YEAR-OLD FEMALE PATIENT UNDERWENT TKA SURGERY USING THE U2 TOTAL KNEE SYSTEM ON (B)(6) 2022, AND THE PATIENT EXPERIENCED INTENSE PAIN AFTER SURGERY. THE X-RAY SHOWED THE FEMORAL COMPONENT LOOSENING. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2026.

  Patient problems: Limb Pain

  MAUDE report 25238428 ↗