NA 412.212Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982210968), received between Nov 20, 2020 and Dec 31, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE FEMORAL NECK SYSTEM IMPLANT HAD TO BE REMOVED DUE TO THE SURGEON CONVERTING TO A TOTAL HIP REPLACEMENT. THE ORIGINAL IMPLANTATION WAS UNKNOWN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY REPORTED. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT DEVICES REPORTED: FEMORAL NECK SYSTEM PLATE 1 HOLE ¿ STERILE (PART NUMBER 04.168.000S, LOT UNKNOWN, QUANTITY 1). BOLT FOR FEMORAL NECK SYSTEM 100MM LENGTH-STERILE (PART NUMBER 04.168.300S, LOT UNKNOWN, QUANTITY 1). ANTIROTATION SCREW FOR FEMORAL NECK SYS 90MM LENGTH ¿ STERILE (PART NUMBER 04.168.490S, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 5.0MM TI LOCKING SCR SLF-TPNG WITH T25 STARDRIVE RECESS 36MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11102010 ↗
• InjuryNov 20, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A REVISION PROCEDURE ON (B)(6) 2020, THE DISTAL LOCKING SCREW HAD TO BE DRILLED OUT DUE TO CROSS THREADING INTO THE FNS PLATE. THE SURGEON HAD DIFFICULTY REMOVING THE DEVICE BECAUSE OF THE COLD WELDING OF THE LOCKING SCREW. ALL THE FNS DEVICES WERE SUCCESSFULLY REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A TWENTY (20) MINUTE SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: FNS BOLT (PART # 04.168.285S, LOT # 46P2080, QUANTITY 1), FNS ANTIROTATION SCREW (PART # 04.168.485S, LOT # UNKNOWN, QUANTITY 1). (B)(4) WILL CAPTURE THE INTRA-OP EVENT OF THE REVISION PROCEDURE WHERE THE DISTAL LOCKING SCREW HAD TO BE DRILLED OUT AS IT WAS CROSS THREADED INTO THE FNS PLATE, WHILE (B)(4) WILL CAPTURE THE POST-OP EVENT WHERE THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO LOSS OF REDUCTION OF THE FEMORAL NECK SYSTEM (FNS). THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCR SLF-TPNG WITH T25 STARDRIVE RECESS 36MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available

  MAUDE report 10877842 ↗
• InjuryNov 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO LOSS OF REDUCTION OF THE FEMORAL NECK SYSTEM (FNS). BEFORE THE REVISION PROCEDURE, THE PATIENT EXPERIENCED PAIN. INITIALLY, THE PATIENT WAS IMPLANTED WITH THE REPORTED DEVICE ON (B)(6) 2020. DURING THE REVISION PROCEDURE, THE DISTAL LOCKING SCREW HAD TO BE DRILLED OUT AS IT WAS CROSS THREADED WITH THE FNS PLATE. ALL THE FNS DEVICES WERE SUCCESSFULLY REMOVED THEN THE PATIENT WAS REVISED TO A TOTAL HIP ARTHROPLASTY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 20-MINUTE SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. (B)(4) WILL CAPTURE THE POST-OP EVENT WHERE THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO LOSS OF REDUCTION OF THE FEMORAL NECK SYSTEM (FNS), WHILE (B)(4) WILL CAPTURE THE INTRA-OP EVENT OF THE REVISION PROCEDURE WHERE THE DISTAL LOCKING SCREW HAD TO BE DRILLED OUT AS IT WAS CROSS THREADED INTO THE FNS PLATE. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCR SLF-TPNG WITH T25 STARDRIVE RECESS 36MM THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Code Available; Pain; Physical Asymmetry

  MAUDE report 10876141 ↗