AESCULAP NX045Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046963810313), received between Jun 6, 2023 and Oct 29, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED TO AESCULAP INC. THAT A AS COLUMBUS REV F FEMUR CEMENTED F5L (PART # NR005Z) WAS IMPLANTED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT THE PATIENT WAS INFECTED AND REQUIRED A REVISION PROCEDURE. REPORTEDLY THE REVISION WAS PERFORMED ON (B)(6) 2024. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: 2916714-2024-00162 (AIC REFERENCE NO. (B)(4), 2916714-2024-00165 (AIC REFERENCE NO. (B)(4), 2916714-2024-00166 (AIC REFERENCE NO. (B)(4), 2916714-2024-00167 (AIC REFERENCE NO. (B)(4), 2916714-2024-00169 (AIC REFERENCE NO. (B)(4), 2916714-2024-00171 (AIC REFERENCE NO. (B)(4), 2916714-2024-00172 (AIC REFERENCE NO. (B)(4), 2916714-2024-00173 (AIC REFERENCE NO. (B)(4), 2916714-2024-00174 (AIC REFERENCE NO. (B)(4), 2916714-2024-00175 (AIC REFERENCE NO. (B)(4).

  Patient problems: Failure of Implant; Implant Pain; Unspecified Infection

  MAUDE report 20561288 ↗
• InjuryOct 29, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED TO AESCULAP INC. THAT A PATELLA 3-PEGS P5 (PART # NX045) WAS IMPLANTED ON OCTOBER 6 2023. ACCORDING TO THE COMPLAINANT THE PATIENT WAS INFECTED AND REQUIRED A REVISION PROCEDURE. REPORTEDLY THE REVISION WAS PERFORMED ON OCTOBER 14 2024. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE XC 100037380 CC 400681245 ASSOCIATED MEDWATCH REPORTS: 2916714-2024-00162 (AIC REFERENCE NO. (B)(4)); 2916714-2024-00165 (AIC REFERENCE NO. (B)(4)); 2916714-2024-00166 (AIC REFERENCE NO. (B)(4)); 2916714-2024-00167 (AIC REFERENCE NO. (B)(4)); 2916714-2024-00168 (AIC REFERENCE NO. (B)(4)); 2916714-2024-00169 (AIC REFERENCE NO. (B)(4)); 2916714-2024-00171 (AIC REFERENCE NO. (B)(4)); 2916714-2024-00172 (AIC REFERENCE NO. (B)(4)); 2916714-2024-00173 (AIC REFERENCE NO. (B)(4)); 2916714-2024-00174 (AIC REFERENCE NO. (B)(4)); 2916714-2024-00175 (AIC REFERENCE NO. (B)(4)).

  Patient problems: Failure of Implant; Implant Pain; Unspecified Infection

  MAUDE report 20557909 ↗
• InjuryJun 6, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP INC. THAT A PATELLA 3-PEGS P5 (PART # NX045) WAS IMPLANTED (B)(6)2020. ACCORDING TO THE COMPLAINANT THE IMPLANT HAD BECOME LOOSE AND THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2023. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). REFERENCE ASSOCIATED MEDWATCH REPORTS: 2916714-2023-00064. 2916714-2023-00069. 2916714-2023-00070. 2916714-2023-00071. 2916714-2023-00073.

  Patient problems: Insufficient Information

  MAUDE report 17074629 ↗