R3 71366438Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 03596010656087), received between Oct 9, 2020 and Jul 14, 2026 — classified as 3 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Crack” (8 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. 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25817997 ↗
• MalfunctionJun 30, 2026Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) R3 LNR MPACTOR HD II 38-42MM BROKE WHEN HITTING THE CUP IN. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25662651 ↗
• MalfunctionOct 31, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, AFTER IMPACTION OF THE DEFINITIVE LINER INTO THE SHELL, IT WAS NOTICED THAT ONE (1) R3 LNR MPACTOR HD II 38-42MM WAS CRACKED IN HALF UPON REMOVAL FROM THE PATIENT. THERE WAS ONE HALF PIECE THAT WAS IN THE PATIENT AND WAS REMOVED IT USING A KOCHER. ALL PIECES WERE REMOVED AND ACCOUNTED FOR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438187 ↗
• MalfunctionAug 14, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY ONE (1) R3 LNR MPACTOR HD II 38-42MM CRACKED WHILE IMPACTING BUT STAYED ATTACHED TO IMPACTOR HANDLE AND WHOLE. NOTHING FELL IN WOUND. ALL BROKEN PIECES WERE ACCOUNTED FOR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SN BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22811478 ↗
• MalfunctionNov 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE R3 LNR MPACTOR HD II 38-42MM BROKE WHILE IMPACTING AN OR3O LINER. NO PIECE OF THE IMPACTOR HEAD WAS LEFT OR FELL IN THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20784366 ↗
• MalfunctionAug 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE R3 LNR MPACTOR HD II 38-42MM BROKE DURING IMPACTION. NONE OF THE PIECES THAT BROKE OFF WENT INTO THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19940087 ↗
• MalfunctionOct 14, 2022Break; Break

  IT WAS REPORTED THAT, TWO R3 LNR MPACTOR HD II 38-42MM ARE BROKEN. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15612144 ↗
• MalfunctionOct 12, 2022Break; Break

  IT WAS REPORTED THAT, TWO (2) R3 LNR MPACTOR HD II 38-42MM WERE FOUND BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15592086 ↗
• MalfunctionFeb 16, 2022Crack; Crack

  IT WAS REPORTED THAT, DURING THE INSPECTION, IT WAS FOUND THAT AN R3 LNR MPACTOR HD II 38-42MM HAVE A CRACK IN THEM. NO CASE WAS INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13540191 ↗
• MalfunctionFeb 14, 2022Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT, THE R3 LNR MPACTOR HD II 38-42MM IS WORN AND CRACKED. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529726 ↗
• MalfunctionDec 27, 2021Crack; Crack

  IT WAS REPORTED THAT, A R3 LNR MPACTOR HD II 38-42MM WAS CRACKED. AS THIS WAS NOTICED DURING INSPECTION, NO CASE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13090478 ↗
• 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 12121614 ↗
• 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 12119343 ↗
• 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 12119325 ↗
• InjuryMar 4, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THA PROCEDURE, THE METAL RING OF A R3 LNR MPACTOR HD II 38-42MM BROKE OFF DURING IMPACTION, PIECES WERE RETRIEVED WITH TWEEZERS. PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE. THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408863 ↗
• MalfunctionJan 4, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING AN OFFICE INSPECTION IT WAS FOUND THAT FOR A R3 LNR MPACTOR HD II 38-42MM, THE TRIAL WAS CRACKED AND NEEDS TO BE REPLACED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11115038 ↗
• InjuryDec 29, 2020Break; Break

  IT WAS REPORTED THAT A R3 LNR IMPACTOR HD II 38-42 MM CRACKED VERTICALLY WHILE IMPACTING A LINER. THIS OCCURRED DURING THR PROCEDURE, INSTRUMENT INSIDE THE PATIENT. NO HARM OR INJURY REPORTED ON PATIENT. PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A LESS THAN 30 MINUTES DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11088917 ↗
• InjuryNov 10, 2020Break; Break

  IT WAS REPORTED THAT WHILE PERFORMING A THR PROCEDURE THE R3 LNR IMPACTOR HD II 38-42MM BROKE WHILE IMPACTING LINER. THE PROCEDURE WAS COMPLETED WITH AN SMITH&NEPHEW BACKUP DEVICE. NO PATIENT HARM OR ADDITIONAL COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10819520 ↗
• MalfunctionOct 9, 2020Crack; Crack

  IT WAS REPORTED THAT DURING A ROUTINE EFIP INSPECTION THE R3 LINER WAS FOUND TO BE CRACKED. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10658912 ↗

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