AESCULAP NP583RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653349944), received between Nov 9, 2020 and Mar 16, 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 16, 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.

• InjuryMar 16, 2026Patient-Device Incompatibility

  ACCORDING TO THE COMPLAINANT, ON (B)(6) 2023, THE PATIENT UNDERWENT REVISION ARTHROPLASTY OF THE RIGHT KNEE DUE TO A FAILED UNICOMPARTMENTAL KNEE REPLACEMENT. DURING THE PROCEDURE, THE COMPONENTS WERE EXPOSED AND REMOVED, AND THE KNEE WAS CONVERTED TO A TOTAL KNEE ARTHROPLASTY. TRIAL COMPONENTS DEMONSTRATED APPROPRIATE ALIGNMENT AND STABILITY. THE FINAL COMPONENTS WERE IMPLANTED USING BONE CEMENT. THE WOUND WAS IRRIGATED AND CLOSED IN LAYERS, AND THE PATIENT WAS TRANSFERRED TO RECOVERY IN GOOD CONDITION WITH NO INTRAOPERATIVE COMPLICATIONS REPORTED. SUBSEQUENTLY, ON (B)(6) 2025, THE PATIENT UNDERWENT AN ADDITIONAL REVISION PROCEDURE OF THE RIGHT KNEE. DURING THE PROCEDURE, THE EXISTING COMPONENTS AND RESIDUAL CEMENT WERE REMOVED. THE FEMUR AND TIBIA WERE PREPARED, AND NEW COMPONENTS WERE IMPLANTED WITH BONE CEMENT. TRIALING DEMONSTRATED STABILITY THROUGH RANGE OF MOTION WITH NO VARUS OR VALGUS LAXITY AND APPROPRIATE PATELLAR TRACKING. THE WOUND WAS CLOSED AND THE PATIENT WAS TRANSFERRED TO RECOVERY IN GOOD CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 24604762 ↗
• InjuryNov 9, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH KNEE COMPONENTS. AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED UNKNOWN CLAIMS, BUT IT IS KNOWN THAT IT RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2016 AND THE REVISION SURGERY OCCURED ON (B)(6) 2017. CEMENT USED: ZIMMER PALACOS CEMENT. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). INVOLVED COMPONENTS: NO165Z (TIBIAL CEMENTED T4 LM). NO188Z (FEMUR CEMENTED F4 LM). NL473 (PE INSERT T4 RM/LM 7MM). NX044 (UNIVERSAL PATELLA P4). NP583R (THREADED PIN, HEADLESS 3.2MMX63MM). ASSOCIATED MEDWATCHES: 2916714-2020-00570. 2916714-2020-00571. 2916714-2020-00572. 2916714-2020-00573.

  Patient problems: Insufficient Information

  MAUDE report 10813483 ↗