REFLECTION 71362299Recalls & reported problems

Summary

The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 03596010443236), received between May 20, 2018 and Dec 31, 2025 — classified as 14 injuries, 101 malfunctions.

The most frequently reported specific device problem is “Break” (63 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 115 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, THE FINAL CUP WAS BEING IMPACTED AND THE REF CUP POSITIONER/IMPACTOR FRACTURED. NO PIECES FELL INTO THE PATIENT. 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 23933832 ↗
• MalfunctionNov 24, 2025Break; Break

  IT WAS REPORTED THAT DURING A THR SURGERY, ONE (1) REF CUP POSITIONER/IMPACTOR BROKE ADJUSTING THE CUP. THE PROCEDURE WAS COMPLETED, AFTER ANY DELAY, USING AN EQUIVALENT S+N BACK UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23640466 ↗
• MalfunctionJul 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, WHILE IMPACTING THE CUP, THE THREADS OF A R3 STRAIGHT SHELL IMPACTOR BROKE OFF. 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 22568834 ↗
• MalfunctionJul 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE SMACK PLATE ON THE END OF ONE (1) REF CUP POSITIONER/IMPACTOR BROKE OFF WHEN IMPACTING THE SHELL IN. 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 22562323 ↗
• MalfunctionFeb 19, 2025Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE THREADS OF ONE (1) REF CUP POSITIONER/IMPACTOR STRIPPED WHEN IMPACTING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21410649 ↗
• MalfunctionJul 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, ON IMPACTION, THE END OF THE REF CUP POSITIONER/IMPACTOR SNAPPED OFF. NOTHING FELL INTO THE PATIENT AS IT WAS USED ON THE OUTSIDE DURING SURGERY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19812357 ↗
• MalfunctionJun 12, 2024Break; Break

  IT WAS REPORTED THAT, WHILE IMPACTING THE ACETABULAR PROTHESIS WITH A HAMMER DURING A THR SURGERY, ONE (1) REF CUP POSITIONER/IMPACTOR BROKE RIGHT AT THE IMPACT PART. 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 19520097 ↗
• MalfunctionApr 25, 2024Corroded; Fracture; Material Deformation; Corroded; Fracture; Material Deformation

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) REF CUP POSITIONER/IMPACTOR BROKE. IT REMAINS UNCERTAIN HOW THE PROCEDURE WAS COMPLETED OR WHETHER THERE WAS ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19182083 ↗
• MalfunctionNov 18, 2023Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, THE STRIKE PLATE OF A REF CUP POSITIONER/IMPACTOR BROKE WHILE USING. 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 18166924 ↗
• MalfunctionNov 13, 2023Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, A REF CUP POSITIONER/IMPACTOR BROKE. IT IS UNKNOWN HOW PROCEDURE WAS COMPLETED OR IF A DELAY OCCURRED DUE TO THIS EVENT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18118633 ↗
• MalfunctionJun 23, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, THE METAL OF ONE (1) REF CUP POSITIONER/IMPACTOR HAS GIVEN WAY. THE IMPACT AREA SNAPPED OFF FROM THE ARM. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 17195879 ↗
• MalfunctionFeb 5, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, AFTER IMPACTION OF THE CUP. THE DISTAL TIP OF THE REF CUP POSITIONER/IMPACTOR DEVICE GOT FRACTURED. NO PIECES FELL INTO 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 16302075 ↗
• MalfunctionNov 4, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, DURING IMPACTION, THE SCREW THAT HOLDS THE REF CUP POSITIONER/IMPACTOR TO THE CUP, BROKE OFF. NO PIECES FELL INTO 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 15728968 ↗
• MalfunctionOct 19, 2022Fracture; Fracture

  IT WAS REPORTED THAT, THE THREADED TIP OF A REF CUP POSITIONER/IMPACTOR SNAPPED OFF. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15635877 ↗
• MalfunctionSep 2, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE SCREW PORTION OF THE REF CUP POSITIONER/IMPACTOR BROKE OFF IN CUP. IT'S UNKNOWN HOW THE PROCEDURE WAS FINISHED OR IF THERE WAS ANY DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353166 ↗
• MalfunctionAug 24, 2022Flaked; Flaked

  IT WAS REPORTED THAT, DURING THR SURGERY, THE THREADS AT THE DISTAL TIP OF THE REF CUP POSITIONER/IMPACTOR WERE SHEARED NOT ALLOWING THE CUP TO BE SCREWED ON. THE PROCEDURE WAS COMPLETED USING AN S+N BACK-UP DEVICE. SURGERY WAS LESS THAN OR EQUAL TO 30 MINS DELAYED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15288632 ↗
• MalfunctionAug 24, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, A REF CUP POSITIONER/IMPACTOR BROKE AT THE TIP WHEN IMPACTING THE CUP. SURGERY WAS COMPLETED, WITH A NON-SIGNIFICANT 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 15282032 ↗
• MalfunctionJul 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, THE THREADED TIP OF A REF CUP POSITIONER/IMPACTOR FRACTURED FROM FATIGUE FROM NORMAL WEAR AND TEAR USAGE. THIS OCCURRED DURING CUP IMPACTION IN THE ACETABULUM, AND THE BROKEN PIECE LODGED IN THE SHELL AS WAS REMOVED FROM THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15090053 ↗
• MalfunctionApr 12, 2022Break; Break

  IT WAS REPORTED THAT, THE DISTAL THREADS OF A REF CUP POSITIONER/IMPACTOR WERE SHEARED. AS THIS WAS NOTICED UPON SET-UP OR INSPECTION FOR THR SURGERY, THE PATIENT WAS NOT INVOLVED AT THAT MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14080054 ↗
• MalfunctionFeb 3, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING FIELD INSPECTION, IT WAS NOTICED THAT THE THREADED PIECE OF THE REF CUP POSITIONER/IMPACTOR HAS SNAPPED OFF. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446648 ↗
• MalfunctionJan 19, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, A REFLECTION CUP POSITIONER/IMPACTOR BROKE. IT IS UNKNOWN IF THIS HAPPENED INTERNALLY OR EXTERNALLY TO THE PATIENT OR IF ANY PIECES FELL INSIDE OF THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13289421 ↗
• MalfunctionJan 19, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, A REFLECTION CUP POSITIONER/IMPACTOR BROKE NEAR HANDLE. IT IS UNKNOWN IF THIS HAPPENED INTERNALLY OR EXTERNALLY TO THE PATIENT OR IF ANY PIECES FELL INSIDE OF THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13289101 ↗
• MalfunctionDec 16, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE TOP OF A HANDLE OF A REF CUP POSITIONER/IMPACTOR BROKE WHILE IMPACTING. AS REPORTED, THE DEVICE BROKE OUTSIDE THE PATIENT AND NO PIECES FELL INTO THE PATIENT. 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 13018540 ↗
• MalfunctionNov 23, 2021Break; Break

  IT WAS REPORTED THAT, A REF CUP POSITIONER/IMPACTOR WAS FOUND WITH THE PUSH AND CLEAN PART BROKEN DURING INSPECTION. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12860515 ↗
• InjuryNov 2, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY A REF CUP POSITIONER/IMPACTOR BROKE WHILE IMPACTING. SURGERY WAS FINISHED WITH A S&N BACKUP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12736463 ↗

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