ENDURO NB019KRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046963165574), received between Feb 1, 2022 and Feb 18, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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.

• InjuryFeb 18, 2022Fracture; Fracture

  IT WAS REPORTED TO AESCULAP AG THAT AN ENDURO FEMORAL COMPONENT CEMENTED F3R (PART # NB019K) WAS IMPLANTED DURING A PRIMARY SURGERY PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, THERE WAS A MATERIAL FRACTURE AT THE JUNCTION OF FEMORAL SHIELD AND STEM. IMPLANTATION WAS DONE DURING TRACHEOESOPHAGEAL PUNCTURE (TEP) EXCHANGE IN 2015. THE CAUSE OF FRACTURE WAS MOST LIKELY LACK OF BONY SUPPORT OF THE SHIELD, RESULTING IN BENDING STRESS AND, IN CASE OF ADIPOSITAS PERMAGNA MATERIAL FATIGUE. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022. A REVISION SURGERY WAS NECESSARY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS NR386K - ENDURO FEMUR SP:ACER POST/DIST F3 4X4MM - LOT 52113336. NR293K - FEMUR EXTENS.STEM 6° D18X77MM CEMENTED - LOT 52135389. NR400K - NUT F/FEMUR EXTENS.STEM ALL SIZES NEUTR. - LOT 52135289. NB013K - ENDURO TIBIAL COMP.OFFSET CEMENTED T3 - LOT 52159428. NB067K - ENDURO TIBIA HEMI-WEDGE T3 12MM RM/LL - LOT 51760228. NB075K - ENDURO TIBIA HEMI-WEDGE T3 4MM RL/LM - LOT 52107302. NR193K - TIBIA OFFSET STEM D18X52MM CEMENTED - LOT 52137131. NR890M - ENDURO MENI

  Patient problems: Failure of Implant

  MAUDE report 13559429 ↗
• InjuryFeb 1, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP AG THAT AN ENDURO FEMORAL COMPONENT CEMENTED F3R (PART # NB019K) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE ENDURO UNCOUPLED WITH LOCKING NUT AND WAS LYING FREELY IN THE JOINT. THE PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNKNOWN DATE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION SURGERY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: (400531692 - NB019K) 9610612-2021-00676 (400530846 - NR891M) INVOLVED COMPONENT: NR891M (ENDURO MENISCAL COMPONENT F3 12MM - LOT 52095496).

  Patient problems: Failure of Implant

  MAUDE report 13416980 ↗