R3 71363077Recalls & reported problems

Summary

The FDA's MAUDE database contains 461 adverse event reports that list this exact device (DI 03596010599391), received between Feb 27, 2019 and Jun 15, 2026 — classified as 69 injuries, 392 malfunctions.

The most frequently reported specific device problem is “Break” (222 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 461 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2026Fracture

  IT WAS REPORTED THAT, DURING THA, ONE (1) R3 OFFSET IMPACTOR WAS CHIPPED. NO PIECES FELL INSIDE 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 25498123 ↗
• MalfunctionJun 3, 2026Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, IT WAS NOTICED THAT ONE (1) R3 OFFSET IMPACTOR TIP BROKE OFF. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25369883 ↗
• MalfunctionMay 31, 2026Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, ONE (1) R3 OFFSET IMPACTOR TIP BROKE WHEN IMPACTING THE CUP. 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 25344132 ↗
• MalfunctionMay 19, 2026Fracture

  IT WAS REPORTED THAT, DURING A THA, ONE (1) R3 OFFSET IMPACTOR TIP BROKE WHILE IMPACTING THE CUP. ALL PIECES WERE FOUND. 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 25215372 ↗
• MalfunctionMay 15, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A THR, THE TIP OF ONE (1) R3 OFFSET IMPACTOR TIP WAS MISSING AND EFFECTIVELY RENDERED USELESS. 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 25194118 ↗
• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) R3 OFFSET IMPACTOR TIP BROKE DURING CUP IMPACTION. 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 25089802 ↗
• MalfunctionMay 3, 2026Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) R3 OFFSET IMPACTOR TIP BROKE INTO TWO PIECES AFTER THE IMPLANT WAS PLACED AND THE IMPACTOR WAS UNSCREWED. THE DOCTOR FISHED OUT THE OTHER PIECE, AND DID TWO WASH OUTS TO MAKE SURE THERE WAS NO SMALLER PIECES LEFT BEHIND. 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 25064274 ↗
• MalfunctionApr 16, 2026Fracture

  IT WAS REPORTED THAT DURING A THR, THE TIP OF TWO (2) R3 OFFSET IMPACTOR TIPS BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24896154 ↗
• MalfunctionApr 9, 2026Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) R3 OFFSET IMPACTOR TIP BROKE INTO 3 PIECES DURING CUP PLACEMENT. ALL PIECES PLUS RING WERE REMOVED FROM 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 24829735 ↗
• MalfunctionMar 20, 2026Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, ONE (1) R3 OFFSET IMPACTOR TIP BROKE INTO 5 TINY PIECES ALL RECOVERED WITH PICKUPS. 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 24650857 ↗
• MalfunctionMar 17, 2026Crack

  IT WAS REPORTED THAT, DURING A THA SURGERY, THE R3 OFFSET IMPACTOR TIP CRACKED DURING IMPACTION. 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 24620065 ↗
• MalfunctionMar 12, 2026Fracture

  IT WAS REPORTED THAT, DURING A THA, ONE (1) R3 OFFSET IMPACTOR TIP BROKE DURING IMPACTION. 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 24582032 ↗
• MalfunctionMar 2, 2026Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE R3 OFFSET IMPACTOR TIP BROKE WHILE ATTEMPTING TO IMPLANT THE R3 SHELL IN THE CASE. ALL BROKEN PIECES WERE RECOVERED AND REMOVED. THE PROCEDURE WAS PERFORMED, 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 24480050 ↗
• MalfunctionFeb 26, 2026Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, THE R3 OFFSET IMPACTOR TIP FRACTURED DURING IMPACTION. 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 24454672 ↗
• MalfunctionFeb 11, 2026Fracture

  IT WAS REPORTED THAT, DURING A THR, SIX (6) R3 OFFSET IMPACTOR TIP CHIPPED DURING STANDARD USAGE, NO PIECES FELL INSIDE 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 24318322 ↗
• MalfunctionFeb 4, 2026Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, UPON IMPLANTATION OF THE R3 CUP, ONE (1) R3 OFFSET IMPACTOR TIP BROKE OFF FROM THE IMPACTOR OR HANDLE. ALL PIECES WERE RECOVERED AND THE WOUND WAS IRRIGATED WITH COPIOUS AMOUNTS OF IRRIGATION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259836 ↗
• MalfunctionFeb 2, 2026Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, ONE (1) R3 OFFSET IMPACTOR TIP BROKE. ALL PIECES WERE FOUND AND ACCOUNTED FOR. 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 24240455 ↗
• MalfunctionJan 27, 2026Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE BLACK TIP OF A R3 OFFSET IMPACTOR TIP CRACKED WHILE IMPACTING BUT STAYED INTACT. NO PIECES WERE LEFT IN THE BODY. NO PIECES FELL INTO PATIENT BODY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING 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 24188540 ↗
• MalfunctionJan 19, 2026Break

  IT WAS REPORTED THAT, DURING A TOTAL HIP PROCEDURE, ONE (1) R3 OFFSET IMPACTOR TIP 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 24109026 ↗
• MalfunctionJan 9, 2026Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) R3 OFFSET IMPACTOR TIP BROKE WHILE IMPACTING THE CUP. THE PROCEDURE WAS PERFORMED, 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 24020832 ↗
• MalfunctionDec 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THA, THE R3 OFFSET IMPACTOR TIP BROKE DURING IMPACTION. 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 23928092 ↗
• MalfunctionDec 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE PLASTIC R3 OFFSET IMPACTOR TIP BROKE DURING IMPACTION. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH AN SIMILAR S+N BACK-UP PRODUCT. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887834 ↗
• MalfunctionDec 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, DURING IMPACTION THE BLACK TIP OF ONE (1) R3 OFFSET IMPACTOR TIP CRACKED AND SPLIT IN HALF. 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 23863236 ↗
• MalfunctionDec 14, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, THE R3 OFFSET IMPACTOR TIP BROKE WHILE DOING CUP IMPLANTATION. IT IS UNKNOWN IF ANY PIECE FELL INSIDE SURGICAL SITE. 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 23799544 ↗
• MalfunctionDec 10, 2025Break; Break

  IT WAS REPORTED THAT, DURING A THA SURGERY, THE TIP OF ONE (1) R3 OFFSET IMPACTOR TIP BROKE DURING CUP IMPACTING. THIS WAS NOTICED AFTER THE CUP WAS IMPLANTED. 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 23771369 ↗