NA 2447-26-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295124818), received between Aug 15, 2017 and Jul 3, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionJul 3, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN INITIAL SURGERY PERFORMED WITH THE IMPLANTS IN QUESTION AT OTHER FACILITY. IT WAS CONFIRMED THAT THE CEMENTLESS STEM AML-PLUS WAS FIXED WITH CEMENT. ON (B)(6) 2009, THE SECOND SURGERY WAS PERFORMED DUE TO THE DISLOCATION OF THE CUP. THE CUP, LINER AND HEAD WERE REPLACE WITH DURALOCK, ENDURON POLYLINER, AND AML HEAD. ON (B)(6) 2025, THE THIRD SURGERY WAS PERFORMED DUE TO THE BREAKAGE OF THE DISTAL STEM WHICH FIXED WITH THE CEMENT. IN THE THIRD REVISION SURGERY, A CENTERING CONE 6MM DRILL WAS USED TO REMOVE THE CEMENT PLUG REMAINING IN THE FEMORAL BONE MARROW. THE PLUG HAD CEMENT ATTACHED AROUND IT, AND IT BROKE INSIDE THE FEMORAL BONE MARROW BEFORE IT COULD BE REACHED. THE BROKEN DRILL WAS RETRIEVED FROM INSIDE THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS RELATED TO (B)(4) WHICH REPORTS THE SECOND SURGERY DUE TO THE CUP DISLOCATION AND (B)(4) WHICH REPORTS THE THIRD SURGERY DUE TO THE STEM BREAKAGE. THIS PC REPORTS THE DRILL BREAKAGE OCCURRED DURING THE THIRD SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 22395428 ↗
• MalfunctionJan 11, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT THE SURGERY VIA THA FOR OA FOR THE HIP JOINT WITH THE PRODUCT IN QUESTION. THE PRODUCT IN QUESTION WAS USED IN A CASE IN WHICH A TEMPORARY BONE WAS FORMED JUST ABOVE THE LESSER TROCHANTER AFTER AN EXTERNAL FEMORAL OSTEOTOMY. THE PRODUCT IN QUESTION WAS DAMAGED BECAUSE THE PATIENT'S TEMPORARY BONE WAS HARD. DUE TO THE PROXIMAL FEMUR, ALL FRAGMENTS WERE REMOVED. IT TOOK ABOUT 2 MINUTES TO REPLACE ANOTHER PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18492081 ↗
• InjuryAug 15, 2017Break; Break

  IT WAS REPORTED THAT A DEPUY DRILL BIT WAS USED TO BUST THROUGH DISTAL CEMENT. THE BIT BROKE OFF IN THE PATIENTS FEMUR AND WAS REALIZED IN THE POST OP FILMS. SURGEON DID NOT WANT TO GO BACK IN AND RETRIEVE THE BROKEN BIT.

  Patient problems: Foreign Body In Patient

  MAUDE report 6794734 ↗