R3 71368569Recalls & reported problems

Summary

The FDA's MAUDE database contains 398 adverse event reports that list this exact device (DI 03596010600240), received between Nov 8, 2018 and May 31, 2026 — classified as 55 injuries, 343 malfunctions.

The most frequently reported specific device problem is “Break” (237 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 25 most recent of 398 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2026Fracture

  IT WAS REPORTED THAT, DURING A RTHA SURGERY, THE JOINT PIECE OF ONE (1) R3 OFFSET IMPACTOR WAS FRACTURED AFTER THE SHELL WOULD NOT UNTHREAD. 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 25341908 ↗
• MalfunctionMay 22, 2026Fracture

  IT WAS REPORTED THAT, DURING AN ASI RIGHT THA SURGERY, WHILE IMPACTING THE ACETABULAR CUP, THE SURGEON FELT AN UNEXPECTED CHANGE IN ONE (1) R3 OFFSET IMPACTOR. AN INTRAOPERATIVE X-RAY WAS TAKEN, WHICH SHOWED A LITTLE PIECE OF METAL IN THE SOFT TISSUE. THE ACETABULAR CUP COULD NOT BE DISENGAGED FROM THE OFFSET IMPACTOR. AS A RESULT, THE CUP WAS REMOVED, AND A STRAIGHT IMPACTOR HANDLE WAS USED TO PROCEED. IT IS UNKNOWN IF THE LITTLE PIECE OF METAL WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25262894 ↗
• MalfunctionMay 14, 2026Fracture

  IT WAS REPORTED THAT, DURING A THR, WHEN DOCTOR TRIED TO REMOVE ONE (1) R3 OFFSET IMPACTOR, IT WOULD NOT RELEASE THE CUP. THEN, REMOVED THE IMPACTOR WITH THE CUP STILL ATTACHED AND NOTICED THE MECHANISM TO HELP SECURE THE CUP WAS BROKEN AND THEREFORE NOT ABLE TO RELEASE THE CUP. THE WOUND WAS CLEAR AND HAD NO PARTS OF THE INSERTER INSIDE. 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 25172845 ↗
• MalfunctionApr 29, 2026Fracture

  IT WAS REPORTED THAT, DURING A THA, THE LOCKING LINKAGE OF ONE (1) R3 OFFSET IMPACTOR BROKE DURING SHELL INSERTION. NO PIECES FELL INSIDE THE WOUND. 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 25029811 ↗
• MalfunctionApr 6, 2026Break; Fracture; Difficult or Delayed Separation

  IT WAS REPORTED THAT, DURING A THA SURGERY, ONE (1) R3 OFFSET IMPACTOR COULD NOT BE UNTHREADED FROM THE R3 CUP AFTER IMPACTION. UPON INVESTIGATION THE JOINTED SHAFT IN THE LOCKING MECHANISM WAS HITTING THE SIDE OF THE IMPACTOR NOT ALLOWING THE SURGEON TO UNSCREW IT. THE PROCEDURE WAS PERFORMED, AFTER A GREATER THAN 30 MIN DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24788804 ↗
• MalfunctionMar 31, 2026Break

  IT WAS REPORTED THAT, DURING A THA, ONE (1) R3 OFFSET IMPACTOR BROKE DURING IMPACTION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24750542 ↗
• MalfunctionMar 30, 2026Break; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) R3 OFFSET 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 24725743 ↗
• MalfunctionMar 6, 2026Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, TWO (2) R3 OFFSET IMPACTOR BROKE UPON IMPACTION. 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 24531601 ↗
• MalfunctionFeb 7, 2026Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY THE LITTLE SCREW THAT GOES INTO THE DISTAL TIP OF ONE (1) R3 OFFSET IMPACTOR BROKE WHEN TRYING TO PUT ON THE R3 TRIAL. NO PIECES FELL INSIDE THE WOUND. NO PATIENT WAS HARMED. 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 24285980 ↗
• MalfunctionFeb 4, 2026Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, THE HINGE OF ONE (1) R3 OFFSET IMPACTOR SNAPPED DURING THE CUP PLACEMENT. 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 24259673 ↗
• MalfunctionJan 25, 2026Break

  IT WAS REPORTED THAT, DURING A THA SURGERY, THE BACK OF ONE (1) R3 OFFSET 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 24175714 ↗
• MalfunctionJan 8, 2026Break

  IT WAS REPORTED THAT, DURING A THA SURGERY, ONE (1) R3 OFFSET 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 24012981 ↗
• MalfunctionJan 7, 2026Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP OF ONE (1) R3 OFFSET IMPACTOR BROKE DURING IMPACTION. THE PROCEDURE WAS PERFORMED, 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 23996654 ↗
• MalfunctionDec 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, THE R3 OFFSET IMPACTOR BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898775 ↗
• MalfunctionDec 26, 2025Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) R3 OFFSET IMPACTOR BROKE AFTER HITTING IT WITH THE MALLET. 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 23897767 ↗
• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED THAT, THE STRIKE PLATE ON THE BACK OF THE R3 OFFSET IMPACTOR BROKE. EVEN THOUGH THE BREAKAGE WAS NOTICED DURING THE CLEANING PROCESS, THE DEVICE WAS STILL USED FOR A THR SURGERY. 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 23889127 ↗
• MalfunctionDec 16, 2025Break; Break

  IT WAS REPORTED THAT, DURING A RIGHT THA SURGERY, ONE (1) R3 OFFSET IMPACTOR BROKE UPON IMPACTION. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED AND IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821212 ↗
• MalfunctionNov 30, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, THE LOCKING MECHANISM OF ONE (1) R3 OFFSET IMPACTOR BROKE DURING IMPACTION OF THE ACETABULAR COMPONENT. THE CUP WAS ABLE TO BE REMOVED AND LOADED ONTO A NEW IMPACTOR. THE CUP WAS NOT DAMAGED DURING THE EVENT AND NO FRAGMENTS WERE LEFT IN THE PATIENT. THE PROCEDURE WAS RESUMED, 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 23677315 ↗
• MalfunctionNov 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, WHEN HITTING THE PAN, IN ONE (1) R3 OFFSET IMPACTOR, THE JOINT OF THE PAN HOLDER BROKE DURING THE INSERTION OF THE HIP SOCKET. IT IS UNKNOWN HOW WAS COMPLETED THE SURGERY OR IF A DELAY WAS REPORTED. NO INJURY TO PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23634931 ↗
• MalfunctionNov 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, WHEN HITTING THE PAN, IN ONE (1) R3 OFFSET IMPACTOR, THE JOINT OF THE PAN HOLDER BROKE DURING THE INSERTION OF THE HIP SOCKET. IT IS UNKNOWN HOW WAS COMPLETED THE SURGERY OR IF A DELAY WAS REPORTED. NO INJURY TO PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23634351 ↗
• MalfunctionNov 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, WHEN HITTING THE PAN, IN ONE (1) R3 OFFSET IMPACTOR, THE JOINT OF THE PAN HOLDER BROKE DURING THE INSERTION OF THE HIP SOCKET. IT IS UNKNOWN HOW WAS COMPLETED THE SURGERY OR IF A DELAY WAS REPORTED. NO INJURY TO PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23634148 ↗
• MalfunctionNov 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN ANTERIOR THR SURGERY, WHILE TRYING TO REMOVE THE R3 OFFSET IMPACTOR FROM THE SHELL, NOTICED IT WAS NOT RELEASING. THE DEVICE BROKE AT THE MOST DISTAL ARTICULATION THAT IS ATTACHED TO THE ORANGE HANDLE THAT ACTS AS THE SCREWDRIVER LOCKING THE SHELL ONTO THE IMPACTOR. TWO OF THE NUTS THAT ATTACH THE TO PIN AND HOLD THE JOINT TOGETHER BROKE AND ONE OF THE NUTS HAD TO BE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS PERFORMED, 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 23605468 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT, DURING A THA SURGERY, THE R3 OFFSET 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 23459804 ↗
• MalfunctionOct 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, USING A R3 OFFSET IMPACTOR, WHILE REMOVING SHELL TRIAL FROM ACETABULUM, IT WAS IMPACTED BOTTOM OF STRIKE PLATE, AND IT BEGAN TO SEPARATE. THE PIECES FELL DOWN IN THE WOUND, THERE WERE REMOVED WITH TWEEZERS, X-RAY NOT AVAILABLE TO SHARE, BUT SHOTS WERE TAKEN AT END OF CASE AND SHOWED NO PIECES REMAINING IN JOINT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A SIMILAR S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23407571 ↗
• MalfunctionOct 23, 2025Break; Break

  IT WAS REPORTED THAT DURING A THR SURGERY, ONE (1) R3 OFFSET IMPACTOR BROKE UPON IMPACTION. THE PROCEDURE WAS COMPLETED WITH A SIMILAR S+N BACK UP PRODUCT, WITH NO DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23364722 ↗

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