NA 4831-36-015Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295515708), received between Mar 22, 2023 and Oct 28, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT 36 PLUS 5 HEAD WAS SCRATCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23405880 ↗
• InjuryJan 3, 2025Entrapment of Device; Off-Label Use; Improper or Incorrect Procedure or Method; Entrapment of Device; Off-Label Use; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A HIP FX CASE, THE SURGEON BEGAN USING RECLAIM MONOBLOC INSTRUMENTS PER TECHNIQUE. THE SURGEON USED THE ENTRY REAMER FOLLOWED BY THE 12MM STANDARD DISTAL REAMER, 13MM STANDARD DISTAL REAMER, AND 14MM STANDARD DISTAL REAMER. THE 14MM STANDARD DISTAL REAMER HAD GOOD CORTICAL ENGAGEMENT AND WAS USED FOR TRIALING. SURGEON PROCEEDED TO USE THE PROXIMAL REAMERS SEQUENTIALLY STARTING WITH THE 12MM STANDARD PROXIMAL REAMER, THE 13MM STANDARD PROXIMAL REAMER, AND FINALLY THE 14MM STANDARD PROXIMAL REAMER. SURGEON ATTACHED THE STANDARD TRIAL NECK AND THE TRIAL 36MM X 1.5MM HEAD. SURGEON REDUCED THE HIP AND PERFORMED RANGE OF MOTION. THE SURGEON REQUESTED IMPLANTS TO MATCH THE TRIALS. SURGEON REMOVED THE HEAD TRIAL AND THE NECK TRIAL. SURGEON BEGAN THE REMOVAL OF THE 14MM STANDARD DISTAL REAMER AND WAS NOT ABLE TO REMOVE IT. SURGEON PROCEEDED TO USE THE POWER REAMER AND WAS NOT ABLE TO REMOVE THE 14MM STANDARD DISTAL REAMER. SURGEON TRIED THE SLAP HAMMER AND WAS UNSUCCESSFUL. SURGEON THEN TRIED THE T-HANDLE FROM THE RECLAIM MONOBLOC INSTRUMENT SET UNSUCCESSFULLY. THE SURGEON DECIDED TO LEAVE THE 14MM STANDARD DISTAL REAMER IN PATIENT, REATTACH THE STANDARD NECK TRI

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 21067571 ↗
• MalfunctionDec 27, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE HEAD TRIALS HAD BECOME WORN OUT AND SCRATCHED OVER TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18398317 ↗
• MalfunctionSep 25, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT TRIAL HEADS ARE SCRATCHED/RUFFED UP. SURGICAL DELAY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17813711 ↗
• MalfunctionAug 23, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE INSIDE SLEEVE OF THE HEAD APPEARS WORN FROM OVERUSE. NO EFFECT ON CASE OUTCOME. UNKNOWN SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17604953 ↗
• MalfunctionMar 29, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON STATES TOLERANCES BETWEEN HEAD AND NECKS OF EMPHASYS WERE TOO TIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16635825 ↗
• MalfunctionMar 24, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON HAD STATED HEAD AND NECK TOLERANCES ARE TOO TIGHT WITH EMPHASYS. THERE WAS A SURGICAL DELAY OF 5 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 16611410 ↗
• MalfunctionMar 24, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON HAD STATED HEAD AND NECK TOLERANCES ARE TOO TIGHT WITH EMPHASYS. THERE WAS A SURGICAL DELAY OF 5 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 16610322 ↗
• MalfunctionMar 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON STATES TOLERANCES BETWEEN HEAD AND NECKS OF EMPHASYS WERE TOO TIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16594029 ↗
• MalfunctionMar 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON STATES TOLERANCES ON ALL EMPHASIS TRIAL NECKS AND HEADS ARE TOO TIGHT. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16592280 ↗