R3 71368570Recalls & reported problems
Smith & Nephew, Inc. · R3 IMPACTOR REPLACEMENT TIP · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Smith & Nephew R3 impactor replacement tip is an orthopedic surgical instrument used in hip surgery. Reports mostly describe the tip breaking, cracking, chipping, or deforming during procedures, sometimes leaving pieces that are retrieved. There are 77 adverse event reports naming it, with no deaths and 4 injuries. No recalls name 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
- 77
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 03596010600257), received between May 30, 2018 and Mar 25, 2026 — classified as 4 injuries, 73 malfunctions.
The most frequently reported specific device problem is “Break” (35 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break35
- Material Deformation18
- Crack11
- Fracture8
- Naturally Worn8
- Flaked3
- Material Fragmentation3
- Degraded2
Patient problems
- No Clinical Signs, Symptoms or Conditions69
- No Patient Involvement7
- No Known Impact Or Consequence To Patient4
- No Consequences Or Impact To Patient3
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2026Fracture
IT WAS REPORTED THAT DURING A THR SURGERY, WHILE IMPACTING THE R3 ACETABULUM FOLLOWING INSTRUCTIONS FOR USE, THE R3 IMPACTOR TIP BROKE INSIDE THE ACETABULUM; HOWEVER, THE FRAGMENTS WERE COMPLETELY REMOVED FROM THE 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 24690950 ↗MalfunctionApr 1, 2025Break; Break
IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) R3 IMPACTOR TIP BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED OR IF THERE WAS ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21749056 ↗MalfunctionMar 18, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR, ONE (1) R3 IMPACTOR TIP BROKE INTO TWO PIECES UPON IMPACTING THE ACETABULUM. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO DELAY OR INJURY WAS REPORTED AS A RESULT OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21628160 ↗MalfunctionJan 23, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, ONE [1] R3 IMPACTOR TIP BROKE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21217088 ↗MalfunctionJun 11, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) R3 IMPACTOR TIP BROKE WHILE IMPACTING THE CUP. ALL PIECES WERE REMOVED FROM 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 19515635 ↗MalfunctionMay 28, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) R3 IMPACTOR TIP BROKE IN HALF WHILE IMPACTING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. ONE OF THE PIECES FELL INTO THE WOUND AND WAS RETRIEVED WITH A TONSIL. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19410308 ↗MalfunctionApr 5, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT, DURING A THR SURGERY, TWO (2) R3 IMPACTOR TIP SPLINTERED WHEN USING THE CUP IMPACTOR. 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 19051608 ↗MalfunctionSep 19, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING A THR SURGERY TWO (2) R3 IMPACTOR TIP CHIPPED. 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 17774131 ↗MalfunctionOct 27, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING THR, THE R3 IMPACTOR TIP BROKE WHILE THE SURGEON WAS INSERTING AN R3 CUP 54MM. 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 15683458 ↗MalfunctionOct 19, 2022Break; Break
IT WAS REPORTED THAT, ONE (1) R3 IMPACTOR TIP WAS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15630669 ↗MalfunctionOct 14, 2022Break; Break
IT WAS REPORTED THAT A R3 IMPACTOR TIP BROKE. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED. UPON INVESTIGATION IT WAS FOUND THAT THE DEVICE IS DEGRADED AND SMALL FRAGMENTS OF MATERIAL BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15611134 ↗MalfunctionOct 14, 2022Break; Degraded; Break; Degraded
IT WAS REPORTED THAT A R3 IMPACTOR TIP BROKE. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15610717 ↗MalfunctionOct 12, 2022Break; Degraded; Material Fragmentation; Break; Degraded; Material Fragmentation
IT WAS REPORTED THAT, ONE (1) R3 IMPACTOR TIP BROKE. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15592072 ↗MalfunctionSep 22, 2022Fracture; Fracture
IT WAS REPORTED THAT AN R3 IMPACTOR TIP WAS FOUND BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15466031 ↗MalfunctionSep 21, 2022Break; Break
IT WAS REPORTED THAT A R3 IMPACTOR TIP IS BROKEN. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15460971 ↗MalfunctionSep 21, 2022Break; Break
IT WAS REPORTED THAT A R3 IMPACTOR TIP IS BROKEN. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15460959 ↗MalfunctionAug 24, 2022Flaked; Flaked
IT WAS REPORTED THAT AN R3 IMPACTOR TIP WAS DAMAGED AND PEELING. AS THIS WAS NOTICED IN A FIELD INSPECTION, NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15288801 ↗MalfunctionJul 28, 2022Break; Break
IT WAS REPORTED THAT, THREE (3) R3 IMPACTOR TIP WERE FOUND BROKEN. AS THIS WAS NOTICE IN A FIELD INSPECTION, NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15126113 ↗MalfunctionJun 11, 2022Break; Break
IT WAS REPORTED THAT, AN R3 IMPACTOR TIP IS BROKEN. 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 14663859 ↗MalfunctionJun 9, 2022Break; Break
IT WAS REPORTED THAT, A R3 IMPACTOR TIP WAS FOUND BROKEN. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVED AT THE MOMENT THIS ISSUE WAS NOTICED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14640581 ↗MalfunctionJun 8, 2022Break; Break
IT WAS REPORTED THAT, A R3 IMPACTOR TIP WAS BROKEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14640252 ↗MalfunctionMar 26, 2022Break; Break
IT WAS REPORTED THAT DURING A FIELD INSPECTION, IT WAS NOTICED THAT THE R3 IMPACTOR TIP IS BROKEN. NOT PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13925084 ↗MalfunctionMar 4, 2022Break; Break
IT WAS REPORTED THAT THREE (3) R3 IMPACTOR TIPS ARE BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13666531 ↗MalfunctionMar 1, 2022Crack; Crack
IT WAS REPORTED THAT AN R3 IMPACTOR TIP HAD DEVELOPED A CRACK. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13636846 ↗MalfunctionFeb 15, 2022Break; Break
IT WAS REPORTED THAT, THREE (3) R3 IMPACTOR TIPS BROKE. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13532696 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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