R3 71366444Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010656094), received between Apr 15, 2019 and Apr 28, 2022 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2022Crack; Crack

  IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT AN R3 LINER IMPACTOR HEADS II 44-48MM FAILED. THE DEVICE HAS A SUPERFICIAL CRACK (DID NOT SEPARATE INTO PIECES). INSTRUMENTS OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. THE PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14231539 ↗
• MalfunctionApr 9, 2022Crack; Crack

  IT WAS REPORTED THAT THE PLASTIC ON THE HEAD OF AN R3 LINER IMPACTOR HEAD II 44-48MM IS 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 14068811 ↗
• MalfunctionJul 6, 2021Crack; Naturally Worn; Scratched Material; Crack; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT A R3 LINER IMPACTOR HEAD II 44-48MM 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 12123100 ↗
• MalfunctionJul 6, 2021Crack; Naturally Worn; Scratched Material; Crack; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT A R3 LINER IMPACTOR HEAD WERE 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 12121616 ↗
• 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 12119344 ↗
• MalfunctionJul 5, 2021Crack; Scratched Material; Crack; Scratched Material

  IT WAS REPORTED THAT, DURING INSPECTION A R3 LNR MPACTOR 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 12119326 ↗
• MalfunctionMay 14, 2019Break; Break

  IT WAS REPORTED THAT DURING A THR PROCEDURE, METAL PART BROKE OFF DURING IMPACTION. ALL PIECES WERE RECOVERED AND NOTHING FELL INTO THE PATIENT OR WAS LEFT IN THE PATIENT. NO HARM TO THE PATIENT WAS RECORDED. S&N BACKUP DEVICE AVAILABLE. NO DELAY RECORDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8610538 ↗
• MalfunctionApr 15, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY WHILE IMPACTION THE IMPACTOR HEAD SHATTERED. A BACKUP WAS IMMEDIATELY AVAILABLE SO THERE WAS NO DELAY TO THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8516083 ↗

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