R3 71366432Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 03596010656063), received between May 30, 2018 and Oct 15, 2025 — classified as 7 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Crack” (17 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 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, IT WAS NOTICED THAT ONE (1) R3 LNR MPACTOR HD II 32MM WAS CHIPPED FROM BEING HIT OFF THE RIM OF THE CUP. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301991 ↗
• MalfunctionNov 13, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, WHEN IMPACTING THE ACETABULAR LINER, THE TIP OF THE R3 LNR IMPACTOR HD II 32MM FRACTURE. NOTHING FELL INSIDE THE WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING 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 20678543 ↗
• MalfunctionMay 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, THE R3 LNR MPACTOR HD II 32MM BROKE DURING IMPLANTATION OF THE LINER. ALL THE PIECES WERE REPORTEDLY RECOVERED USING FORCEPS. SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19270763 ↗
• MalfunctionFeb 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, THE HEAD OF THE R3 LNR MPACTOR HD II 32MM CRACKED DURING SURGERY WHILE IMPACTING LINER. PIECES WERE RETRIEVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18792705 ↗
• MalfunctionNov 9, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, THE R3 LNR MPACTOR HD II 32MM BROKE INSIDE THE PATIENT. SURGERY WAS PERFORMED AFTER A NON-SIGNIFICANT DELAY. IT IS UNKNOWN HOW SURGERY WAS FINISHED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18100545 ↗
• InjuryDec 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, ONE (1) R3 LNR MPACTOR HD II 32MM BROKE WHILE BEING IMPACTED. ALL PIECES WERE RECOVERED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING 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 15948811 ↗
• MalfunctionOct 27, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR, ONE R3 LNR MPACTOR HD II 32MM BROKE WHILE THE SURGEON WAS INSERTING AN R3 CUP 54MM. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING 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 15683465 ↗
• MalfunctionOct 14, 2022Break; Break

  IT WAS REPORTED THAT, TWO R3 LNR MPACTOR HD II 32MM ARE BROKEN. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15610806 ↗
• MalfunctionOct 12, 2022Break; Break

  IT WAS REPORTED THAT, ONE (1) R3 LNR MPACTOR HD II 32MM WAS FOUND BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15592130 ↗
• MalfunctionOct 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT TWO (2) R3 LNR MPACTOR HD II 32MM ARE BROKEN. AS THIS WAS NOTICED DURING FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15591449 ↗
• MalfunctionSep 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THR, WHILE IMPACTING A LINER INTO THE CUP, THE BLUE PLASTIC TIP ON THE END OF THE R3 LNR MPACTOR HD II 32MM BROKE OFF INTO 5 TO 6 PIECES. IT IS UNKNOW IF ANY PIECE FELL INTO THE PATIENT, HOW THE SURGERY WAS FINISHED. NO INJURY OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15386135 ↗
• MalfunctionApr 21, 2022Crack; Crack

  IT WAS REPORTED THAT, DURING THR, THE BLUE PORTION OF THE R3 LNR MPACTOR HD II 32MM CRACKED. NO PIECES BROKE OFF. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO DELAYS REPORTED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14177168 ↗
• MalfunctionApr 11, 2022Crack; Crack

  IT WAS REPORTED THAT THE PLASTIC ON THE HEAD OF AN R3 LINER IMPACTOR HEAD II 32MM 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 14075145 ↗
• MalfunctionFeb 16, 2022Crack; Crack

  IT WAS REPORTED THAT, DURING INSPECTION, IT WAS FOUND THAT AN R3 LNR MPACTOR HD II 32MM HAVE A CRACK IN THEM. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13540185 ↗
• MalfunctionFeb 16, 2022Crack; Crack

  IT WAS REPORTED THAT, DURING INSPECTION, IT WAS FOUND THAT AN R3 LNR MPACTOR HD II 32MM HAS A CRACK IN IT. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13540180 ↗
• MalfunctionFeb 10, 2022Crack; Degraded; Crack; Degraded

  IT WAS REPORTED THAT, DURING SET UP FOR A THR SURGERY, IT WAS NOTICED THAT TWO R3 LNR IMPACTOR HD II 32MM HAS CRACKED IN THEM DUE TO WEAR. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAY. SINCE THE INCIDENT OCCURRED BEFORE THE PROCEDURE, THE PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13506166 ↗
• MalfunctionFeb 2, 2022Crack; Crack

  IT WAS REPORTED THAT, DURING A THR SURGERY, A R3 LNR MPACTOR HD II 32MM HAS DEVELOPED A CRACK IN SIDING. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13428955 ↗
• InjuryJan 4, 2022Crack; Crack

  IT WAS REPORTED THAT, DURING A TOTAL HIP REPLACEMENT, THE TIP OF A R3 LINER IMPACTOR HEAD 32MM CRACKED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED BEYOND THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13159515 ↗
• InjuryDec 10, 2021Crack; Crack

  IT WAS REPORTED THAT DURING IMPACTION OF THE LINER, THE R3 LNR MPACTOR HD II 32MM CRACKED. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED OR IF THERE WAS A SURGICAL DELAY. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12974620 ↗
• MalfunctionNov 17, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, AN R3 LINER IMPACTOR HEAD II 32MM BROKE OFF. NO BROKEN PIECES FELL INTO THE PATIENT, INSTRUMENT WAS OUTSIDE THE PATIENT. SURGERY WAS COMPLETED WITH A BACKUP DEVICE, WITHOUT ANY DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12831979 ↗
• MalfunctionSep 24, 2021Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT, A R3 LNR MPACTOR HD II 32MM AND R3 LNR MPACTOR HD II 36MM WERE WORN AND CRACKED. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12530577 ↗
• MalfunctionJun 22, 2021Break; Break

  IT WAS REPORTED THAT A R3 LNR MPACTOR HD II 32MM BROKE. INCIDENT OCCURRED DURING SET UP OR INSPECTION; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038835 ↗
• MalfunctionMay 13, 2021Crack; Crack

  IT WAS REPORTED THAT DURING SET UP FOR A THR, IT WAS NOTICED THAT THE LNR IMPACTOR HD II 32MM WAS CRACKED. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11822307 ↗
• MalfunctionMay 13, 2021Crack; Crack

  IT WAS REPORTED THAT AFTER A THR, IT WAS NOTICE THAT THE R3 LNR MPACTOR HD II 32MM (CASE-(B)(4)) AND THE R3 LNR MPACTOR HD II 36MM (CASE (B)(4)) WERE CRACK. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICES AND NO SURGICAL DELAY WAS REPORTED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816878 ↗
• MalfunctionApr 21, 2021Crack; Crack

  IT WAS REPORTED THAT THE R3 LNR MPACTOR HD II 32MM HEAD IMPACTOR CRACKED. THE EVENT OCCUR DURING USE IN A THR SURGERY OUTSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704319 ↗

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