R3 71366451Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010656100), received between Mar 28, 2021 and Mar 20, 2022 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Crack” (6 reports).

2 other recalls cover devices cleared under the same FDA submission (K123598); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2022Crack; Crack

  IT WAS REPORTED THAT A R3 LINER IMPACTOR HEAD II 50-54MM WAS FOUND TO BE CRACKED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13831437 ↗
• MalfunctionJul 6, 2021Crack; Naturally Worn; Scratched Material; Crack; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT A R3 LINER IMPACTOR HEAD II 50-54MM IS SCRATCHED, CRACKED AND WORN DOWN. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12123102 ↗
• MalfunctionJul 6, 2021Crack; Naturally Worn; Scratched Material; Crack; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT A R3 LINER IMPACTOR HEAD II WAS SCRATCHED, CRACKED AND WORN. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12121979 ↗
• MalfunctionJul 5, 2021Crack; Naturally Worn; Scratched Material; Crack; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT A R3 LINER IMPACTOR HEAD II WAS SCRATCHED, CRACKED AND WORN. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12119350 ↗
• MalfunctionJul 5, 2021Crack; Scratched Material; Crack; Scratched Material

  IT WAS REPORTED THAT, DURING INSPECTION A R3 LNR IMPACTOR HD II WAS NOTICED SCRATCHED AND CRACKED. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12119333 ↗
• InjuryMay 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR, A R3 LNR MPACTOR HD II 50-54MM BROKE WHILE BEING USED AS A SECONDARY CUP IMPACTOR. INSTRUMENT WAS BEING USED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A S+N BACK-UP DEVICE. SURGERY WAS LESS THAN OR EQUAL TO 30 MIN DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797916 ↗
• MalfunctionMar 28, 2021Crack; Crack

  IT WAS REPORTED THAT DURING A THR A R3 LNR MPACTOR HD II 50-54MM CRACKED INTO TWO PIECES. THE SURGERY WAS COMPLETED WITH A BACK UP, NO DELAYS AND NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580407 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.

• Z-0730-2019 · Jan 7, 2019 · Terminated
  SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
• Z-1008-2017 · Nov 16, 2016 · Terminated
  REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116