R3 71364450Recalls & reported problems

Summary

The FDA's MAUDE database contains 520 adverse event reports that list this exact device (DI 03596010607034), received between Dec 7, 2017 and Jun 22, 2026 — classified as 47 injuries, 473 malfunctions.

The most frequently reported specific device problem is “Break” (266 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 520 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2026Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) R3 STRAIGHT SHELL IMPACTOR EXPERIENCED BREAKAGE OF THE FINAL THREAD DURING IMPACTION. THE BROKEN FRAGMENT WAS RETRIEVED, AND NO MATERIAL WAS LEFT IN THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; HOWEVER, THERE WAS NO DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25572891 ↗
• MalfunctionJun 17, 2026Fracture; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT, DURING A THA, ONE (1) R3 STRAIGHT SHELL IMPACTOR HAD DAMAGED THREADS DURING IMPACTION. 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 25532240 ↗
• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THAT, DURING A THA SURGERY, THE TIP OF ONE (1) R3 STRAIGHT SHELL IMPACTOR BROKE. 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 25211730 ↗
• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE MIDDLE J-HOOK OF ONE (1) R3 STRAIGHT SHELL IMPACTOR WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A EQUIVALENT S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211724 ↗
• MalfunctionApr 28, 2026Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, THE THREAD ON R3 STRAIGHT SHELL IMPACTOR WAS CHIPPED. UNABLE TO THREAD ON CUP AND LINER IMPACTOR. NO FRAGMENTS WENT INTO THE BODY. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25016904 ↗
• MalfunctionMar 31, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL HIP ARTHROPLASTY (THA) SURGERY, THE TIP OF ONE (1) R3 STRAIGHT SHELL IMPACTOR WAS FOUND TO BE BROKEN, RESULTING IN IMPROPER SEATING OF THE ACETABULAR CUP. THE PROCEDURE WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY USING AN EQUIVALENT SMITH & NEPHEW BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747970 ↗
• MalfunctionMar 30, 2026Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE STRIKE PLATE OF ONE (1) R3 STRAIGHT SHELL IMPACTOR BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24725770 ↗
• MalfunctionMar 4, 2026Material Fragmentation

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP SHREDDED. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH AN EQUIVALENT S+N BACK-UP PRODUCT. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505313 ↗
• MalfunctionJan 5, 2026Fracture

  IT WAS REPORTED THAT DURING A THR, THE R3 STRAIGHT SHELL IMPACTOR BROKE WHILE STRIKING, AND THE ENTIRE IMPACTOR HEAD DETACHED FROM THE STEM; NO PARTS WERE LEFT IN THE PATIENT. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958956 ↗
• MalfunctionJan 5, 2026Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, ONE (1) R3 STRAIGHT SHELL IMPACTOR BROKE. 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 23956700 ↗
• MalfunctionDec 2, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE R3 STRAIGHT SHELL IMPACTOR WAS NOT SECURE BUT WAS ABLE TO ATTEMPT TO IMPACT CUP INTO ACETABULUM. IT WAS BROKEN AT THREADED PART. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACK-UP DEVICE. NO DELAY WAS REPORTED. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693425 ↗
• MalfunctionOct 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, THE THREADS ON DISTAL TIP OF ONE (1) R3 STRAIGHT SHELL IMPACTOR WERE SHEARED NOT ALLOWING IT TO BE SCREWED ONTO CUP. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23306724 ↗
• MalfunctionSep 28, 2025Break; Break

  IT WAS REPORTED THAT DURING A HIP REPLACEMENT SURGERY, THE COIL OF A R3 STRAIGHT SHELL IMPACTOR BROKE. 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 23164072 ↗
• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE R3 STRAIGHT SHELL IMPACTOR BROKE. IT IS UNKNOWN HOW WAS COMPLETED THE SURGERY OR IF A SURGICAL DELAY WAS PRESENTED. NO INJURY TO PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531632 ↗
• MalfunctionJul 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, THE THREADS IN A R3 STRAIGHT SHELL IMPACTOR BROKE OFF TRYING TO PUT THE CUP IN. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THIS CAUSES ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22508736 ↗
• MalfunctionMay 9, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING THR, ONE (1) R3 STRAIGHT SHELL IMPACTOR BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21996756 ↗
• MalfunctionMay 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP OF ONE (1) R3 STRAIGHT SHELL IMPACTOR SNAPPED OFF DURING INSERTION. THE PIECE WAS RETRIEVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21978191 ↗
• MalfunctionMay 6, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT, A R3 STRAIGHT SHELL IMPACTOR BROKE IN SURGERY. THE PROCEDURE WAS RESUMED, USING A S+N BACK-UP DEVICE. IT IS UNKNOWN IF A SURGICAL DELAY HAPPENED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971226 ↗
• MalfunctionApr 11, 2025Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT, DURING THR SURGERY, THE METAL TIP OF ONE (1) R3 STRAIGHT SHELL IMPACTOR BROKE OFF. THE ORANGE IMPACTOR TIP WAS UNABLE TO BE REMOVED DUE TO THE END BREAKAGE. ALL PIECES WERE ACCOUNTED FOR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE. PATIENT LEFT SURGERY IN GOOD HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21829751 ↗
• MalfunctionMar 20, 2025Break; Break

  IT WAS REPORTED THAT DURING A THR SURGERY, THE R3 STRAIGHT SHELL IMPACTOR BROKE WHEN IMPACTED. 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 21654000 ↗
• MalfunctionMar 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, WHILE IMPACTING THE IMPLANT, SURGEON NOTED THAT THE COLLAR HOLDING THE ALIGNMENT X-BAR POST, HAD BROKEN OFF THE SHAFT OF THE R3 STRAIGHT SHELL IMPACTOR. THE X-BAR WAS REMOVED. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21628014 ↗
• MalfunctionMar 5, 2025Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT, DURING A THR SURGERY, WHEN IMPACTING THE SMITH AND NEPHEW CUP, THE THREAD ON THE BOTTOM OF THE R3 STRAIGHT SHELL IMPACTOR PARTLY CRACKED AND SHEARED OFF. HAPPENED EXTERNAL TO PATIENT. THERE WAS NO CUSTOMER IMPACT AS THIS WAS SPOTTED, AND NO ADVERSE EVENT HAPPENED FOR THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21531781 ↗
• MalfunctionFeb 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, THE R3 STRAIGHT SHELL IMPACTOR BROKE. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21493184 ↗
• MalfunctionFeb 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, THE THREADS OF A (1) R3 STRAIGHT SHELL IMPACTOR BROKE OFF WHEN SURGEON WAS IMPACTING THE CUP, AND A (1) R3 IMPACTOR TIP REMAINED STUCK ON THE BROKEN THREADS. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE, OR IF THERE WAS ANY SURGICAL DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21458685 ↗
• MalfunctionFeb 18, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A THR, THE THREADS ON A R3 STRAIGHT SHELL IMPACTOR BROKE. THERE WAS A NON-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 21402830 ↗