REFLECTION 71364022Recalls & reported problems

Summary

The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 03596010479129), received between Jun 14, 2018 and May 31, 2026 — classified as 19 injuries, 112 malfunctions.

The most frequently reported specific device problem is “Break” (92 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 131 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2026Break

  IT WAS REPORTED THAT, DURING A THA SURGERY, THE TIP OF ONE (1) OFFSET REF CUP POS/IMPACTOR BROKE UPON IMPACTION OF THE CUP. 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 25343082 ↗
• MalfunctionDec 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE HEAD OF ONE (1) OFFSET REF CUP POS/IMPACTOR BROKE OFF AND FELL ON THE FLOOR WHILE IMPACTING R3 SHELL, NO PARTS OF THE DEVICE FELL IN THE WOUND. SINCE THE SURGEON WAS DONE IMPACTING THE SHELL, THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23922476 ↗
• MalfunctionDec 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THA, WHILE IMPACTING THE CUP, THE ROUND END OF THE OFFSET REF CUP POS/IMPACTOR SNAPPED OFF. NO PIECES FELL INSIDE THE WOUND. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH AN EQUIVALENT S+N BACK-UP PRODUCT. NO PIECES FELL INSIDE THE WOUND AND NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23899033 ↗
• MalfunctionDec 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, THE PLASTIC TIP OF ONE (1) OFFSET REF CUP POS/IMPACTOR BROKE. THERE WAS NO PLASTIC INSIDE THE PATIENT. 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 23779717 ↗
• MalfunctionNov 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THA SURGERY, DURING IMPACTION, THE PLASTIC TIP OF AN OFFSET REF CUP POS/IMPACTOR CRACKED AND BROKE OFF. NO PIECES 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 23605194 ↗
• MalfunctionAug 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE WELD AT THE TOP OF THE HANDLE OF AN OFFSET REF CUP POS/IMPACTOR, WHERE THE IMPACTING IS DONE, BROKE OFF. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL 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 22767936 ↗
• MalfunctionJun 11, 2025Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, ONE (1) OFFSET REF CUP POS/IMPACTOR BROKE AFTER IMPACTING. 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 22184437 ↗
• MalfunctionJun 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE PLATE OF A OFFSET REF CUP POS/IMPACTOR FELL OFF. 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 22129735 ↗
• MalfunctionMay 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE GRAY CAPS OF TWO (2) OFFSET REF CUP POS/IMPACTOR HAVE BROKEN WHILE IN USE. ALL PIECES RECOVERED. 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 22024863 ↗
• MalfunctionMay 6, 2025Break; Break

  IT WAS REPORTED THAT DURING A THR SURGERY, ONE (1) OFFSET REF CUP POS/IMPACTOR BROKE DURING THE CASE. 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 21971234 ↗
• MalfunctionOct 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE STRIKE PLATE AT THE END OF ONE (1) OFFSET REF CUP POS/IMPACTOR SEPARATED. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20435483 ↗
• MalfunctionSep 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE TIP END PIECE OF THE OFFSET REF CUP POS/IMPACTOR CAME OFF. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20152370 ↗
• MalfunctionSep 2, 2024Fracture; Solder Joint Fracture; Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT, DURING A THR, THE TIP OF A OFFSET REF CUP POS/IMPACTOR BROKE ON IMPACTION. ALL PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 20118506 ↗
• MalfunctionAug 27, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING MALLET IMPACTION IN A THR SURGERY, THE TOP OF ONE (1) OFFSET REF CUP POS/IMPACTOR BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO SURGICAL DELAY. NO INJURY WAS REPORTED AS RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20080996 ↗
• MalfunctionAug 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT, WHILE CUP IMPACTING IN A THR SURGERY, THE TIP OF ONE (1) OFFSET REF CUP POS/IMPACTOR FRACTURED. HOWEVER, IT WAS NOTICED EXTERNALLY FROM THE PATIENT. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19930170 ↗
• MalfunctionMay 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE INTERNAL SCREW OF AN OFFSET REF CUP POS/IMPACTOR BROKE DURING REMOVAL FROM THE CUP. NO PIECES FELL INTO THE PATIENT. 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 19377170 ↗
• MalfunctionMay 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE GREY TIP OF THE OFFSET REF CUP POS/IMPACTOR DEVICE SPLIT ON IMPACTION, ALL PIECES WERE ACCOUNTED FOR AND NOTHING WAS LEFT IN PATIENT. 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 19336740 ↗
• MalfunctionMay 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, ONE (1) OFFSET REF CUP POS/IMPACTOR FRACTURED IN HALF UPON IMPACTION. THE PIECE WAS STILL ATTACHED TO THE IMPACTOR WHEN REMOVED; THEREFORE, NO PIECES FELL INSIDE THE PATIENT AND ALL PIECES WERE ACCOUNTED FOR. THE PROCEDURE WAS PERFORMED WITHOUT ANY DELAY USING THE SAME DEVICE. NO INJURIES WERE REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19288760 ↗
• MalfunctionApr 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, THE IMPACTING PORTION OF THE OFFSET REF CUP POS/IMPACTOR, BROKE OFF DURING IMPLANTATION. NO HARM TO PATIENT OR STAFF; ALTHOUGH, 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 19156188 ↗
• MalfunctionJan 18, 2024Crack; Fracture; Crack; Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE IMPACTOR CRACKED MID CASE, THIS WAS NOTICED AFTER THE ACETABULAR LINER WAS IMPLANTED SAFELY WITH NO ISSUES. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. FURTHERMORE, AFTER SURGERY, WHILE CLEANING, THE CRACKED PIECE OF THE IMPACTOR BROKE OFF. SINCE THE BREAKAGE OCCURRED AFTER SURGERY, PATIENT WAS NO LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18540380 ↗
• MalfunctionDec 31, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, THE OFFSET REF CUP POS/IMPACTOR BROKE IN HALF BY HANDLE WHILE IMPACTING. NO PIECES FELL INTO PATIENT. THE LARGE PIECE FELL ON FLOOR AND WAS RECOVERED. SURGERY WAS PERFORMED AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18423045 ↗
• MalfunctionNov 24, 2023Fracture; Fracture

  IT WAS REPORTED THAT, ON IMPACTION DURING A THR SURGERY, THE END PIECE OF AN OFFSET REF CUP POS/IMPACTOR SNAPPED OFF. NOTHING FELL IN THE PATIENT. 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 18204455 ↗
• MalfunctionNov 24, 2023Fracture; Fracture

  IT WAS REPORTED THAT, ON IMPACTION DURING A THR SURGERY, THE END PIECE OF AN OFFSET REF CUP POS/IMPACTOR SNAPPED OFF. NOTHING FELL IN THE PATIENT. 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 18204441 ↗
• MalfunctionOct 31, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, THE HEAD OF AN OFFSET REF CUP POS/IMPACTOR BROKE OFF. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 18039328 ↗
• MalfunctionOct 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, WHILE IMPLANTING THE ACETABULAR COMPONENT DURING A THR SURGERY, THE ROUND END OF AN OFFSET REF CUP POS/IMPACTOR CAME OFF AND FELL OFF THE FIELD. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE AND THE BROKEN PART WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17912444 ↗

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