REFLECTION 71364071Recalls & reported problems
Smith & Nephew, Inc. · REFLECTION MINAMALLY INVASIVE OFFSET CUP POSITIONER/IMPACTOR TIP · Class 1
Quick summary
This Smith & Nephew Reflection minimally invasive offset cup positioner/impactor tip is a surgical tool used to place and screw the metal cup into the hip during total hip replacement. The 54 reports mostly describe the plastic tip breaking, cracking or snapping during hip surgery, sometimes leaving pieces that had to be removed from the wound;45 reports are malfunctions and 9 involve injuries, with no deaths. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 54
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 03596010493255), received between Jan 10, 2019 and Jun 2, 2025 — classified as 9 injuries, 45 malfunctions.
The most frequently reported specific device problem is “Break” (29 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.
Reports received per month
Most reported problems
Device problems
- Break29
- Fracture15
- Crack10
Patient problems
- No Clinical Signs, Symptoms or Conditions48
- No Consequences Or Impact To Patient4
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2025Break; Break
IT WAS REPORTED THAT DURING A THR SURGERY, ONE (1) MI OFFSET CUP POS/IMP TIP BROKE WHEN THE CUP WAS BEING SCREWED ON DURING 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 22124391 ↗MalfunctionMay 28, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING THR SURGERY ONE (1) MI OFFSET CUP POS/IMP TIP BROKE DURING CUP IMPACTION. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22096672 ↗MalfunctionJan 5, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A THR SURGERY, THE PLASTIC TIP OF A MI OFFSET CUP POS/IMP TIP CRACKED AFTER IMPACTION. 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 18451932 ↗MalfunctionAug 30, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING SURGERY, ONE (1) MI OFFSET CUP POS/IMP TIP WAS BROKEN INTO PIECES, ALL PIECES WERE REMOVED FROM WOUND. 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 17651095 ↗MalfunctionApr 18, 2023Break; Break
IT WAS REPORTED THAT DURING THR SURGERY, A MI OFFSET CUP POS/IMP TIP BROKE AFTER IMPACTION OF CUP. NO PIECES FELL INTO PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16763361 ↗MalfunctionFeb 1, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, A PIECE ON THE END OF THE MI OFFSET CUP POS/IMP TIP BROKE IN HALF. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16277922 ↗MalfunctionJan 30, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING A THR, THE TIP OF ONE (1) MI OFFSET CUP POS/IMP TIP FRACTURED AFTER IMPACTING CUP. NO PIECES FELL INTO 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 16267897 ↗MalfunctionJan 10, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING A THR SURGERY, THE TIP OF (2) TWO MI OFFSET CUP POS/IMP TIP DEVICES BROKE IN HALF UPON IMPACTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO PIECES FELL INTO THE PATIENT. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16134729 ↗MalfunctionNov 14, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING A THR, ONE MI OFFSET CUP POS/IMP TIP BROKE. 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 15787097 ↗MalfunctionNov 14, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING A THR, ONE (1) MI OFFSET CUP POS/IMP TIP BROKE DURING IMPACTION OF CUP. 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 15787020 ↗MalfunctionNov 4, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, A MI OFFSET CUP POS/IMP TIP WAS FRACTURED WHILE IMPACTING CUP, NO PIECES FELL INTO 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 15724852 ↗MalfunctionSep 22, 2022Break; Break
IT WAS REPORTED THAT, DURING A THR, A MI OFFSET CUP POS/IMP TIP BROKE. HOWEVER, NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A S+N BACKUP DEVICE. THE PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15467415 ↗MalfunctionSep 22, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, A MI OFFSET CUP POS/IMP TIP BROKE. NO PIECES FELL INTO 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 15467011 ↗MalfunctionSep 22, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR PROCEDURE, A MI OFFSET CUP POS/IMP TIP BROKE. NO PIECES FELL INTO 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 15466196 ↗MalfunctionSep 22, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR PROCEDURE, A MI OFFSET CUP POS/IMP TIP BROKE. NO PIECES FELL INTO 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 15466172 ↗MalfunctionAug 18, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING A TOTAL HIP REPLACEMENT, TWO (2) MI OFFSET CUP POS/IMP TIPS BROKE ON IMPACTION. NO PIECES FELL INSIDE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15254845 ↗MalfunctionJul 29, 2022Fracture; Fracture
IT WAS REPORTED THAT, TWO (2) MI OFFSET CUP POS/IMP TIP WERE BROKEN. IT IS BELIEVED THEY CRACKED AT SOME POINT AND FELL APART IN THE WASH. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15136432 ↗MalfunctionMar 26, 2022Crack; Crack
IT WAS REPORTED THAT THE MI OFFSET CUP POS/IMP TIP HAS A CRACK IN IT. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13925075 ↗MalfunctionMar 23, 2022Crack; Crack
IT WAS REPORTED THAT THE MI OFFSET CUP POS/IMP TIP HAS A CRACK IN IT. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13870305 ↗MalfunctionMar 23, 2022Crack; Crack
IT WAS REPORTED THAT THE MI OFFSET CUP POS/IMP TIP HAS A CRACK IN IT. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13870291 ↗MalfunctionFeb 24, 2022Break; Break
IT WAS REPORTED THAT DURING THR, THE MI OFFSET CUP POS/IMP TIP BROKE. FURTHER INFORMATION IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 13595826 ↗MalfunctionFeb 10, 2022Break; Break
IT WAS REPORTED THAT THREE (3) REFLECTION MINIMALLY INVASIVE OFFSET CUP POSITIONER/IMPACTOR TIPS BROKE. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13510623 ↗MalfunctionDec 28, 2021Break; Break
IT WAS REPORTED THAT, DURING A THR SURGERY, A MI OFFSET CUP POS/IMP TIP BROKE UPON OPENING THE TRAY. THIS HAPPENED BEFORE USE IN PATIENT. SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A SN BACK-UP DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13101460 ↗MalfunctionDec 20, 2021Break; Break
IT WAS REPORTED THAT, THREE (3) MI OFFSET CUP POS/IMP TIPS ARE BROKEN. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13047505 ↗MalfunctionDec 20, 2021Break; Break
IT WAS REPORTED THAT, THREE (3) MI OFFSET CUP POS/IMP TIPS ARE BROKEN. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13047485 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.