R3 71366436Recalls & reported problems
Smith & Nephew, Inc. · R3 LINER IMPACTOR HEAD II 36MM · Class 2
Quick summary
This Smith & Nephew R3 liner impactor head is a surgical instrument used to hammer hip replacement liners into place during hip surgery. The 57 reports mostly describe the metal head breaking, cracking or splitting apart when struck with a mallet, sometimes leaving pieces that had to be picked up by hand. Five injuries and no deaths are reported, and most cases note no harm to the patient. There are no recalls. Reports rose from 1 to 7 in the past 12 months.
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
- 57
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 03596010656070), received between Sep 6, 2018 and Mar 26, 2026 — classified as 5 injuries, 52 malfunctions.
The most frequently reported specific device problem is “Break” (27 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.
Reports received per month
Most reported problems
Device problems
- Break27
- Fracture17
- Crack14
- Naturally Worn4
- Scratched Material3
- Connection Problem1
- Material Deformation1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions51
- No Known Impact Or Consequence To Patient4
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2026Break; Crack
IT WAS REPORTED THAT, DURING A THA, ONE R3 LNR MPACTOR HD II 36MM BROKE AFTER 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 24698959 ↗MalfunctionFeb 4, 2026Fracture
IT WAS REPORTED THAT DURING A THR SURGERY, AFTER IMPACTING ONE (1) R3 LNR MPACTOR HD II 36MM, A PIECE OF IMPACTOR BROKE OFF, AND IT WAS RETRIEVED BY HAND. THE PROCEDURE WAS COMPLETED, AFTER NO DELAY, USING THE SAME S+N PRODUCT. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24257973 ↗MalfunctionJan 29, 2026Fracture
IT WAS REPORTED THAT, DURING A THA SURGERY, ONE (1) R3 LNR MPACTOR HD II 36MM BROKE WHEN BEING MALLETED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24215496 ↗MalfunctionDec 16, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A THA SURGERY, ONE (1) R3 LNR MPACTOR HD II 36MM SPLIT IN HALF UPON IMPACTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT (32MM LINER IMPACTOR HEAD). NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23822294 ↗MalfunctionDec 16, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) R3 LNR MPACTOR HD II 36MM BROKE OFF AFTER BEING STRUCK WITH MALLET. ALL PIECES RETRIEVED BY HAND OFF THE TABLE. NOTHING FELL INTO PATIENT. THE PROCEDURE WAS COMPLETED, AFTER NO DELAY, USING THE SAME S+N PRODUCT. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23816531 ↗MalfunctionDec 1, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A THR, THE R3 LNR MPACTOR HD II 36MM BROKE WHILE IMPACTING THE SHELL. 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 23688719 ↗MalfunctionNov 4, 2025Fracture; Material Deformation; Fracture; Material Deformation
IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP OF ONE (1) R3 LNR MPACTOR HD II 36MM BROKE WHILE IMPACTING LINER INTO CUP. ALL BROKEN PIECES WERE RECOVERED. 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 23462360 ↗MalfunctionMar 5, 2025Break; Break
IT WAS REPORTED THAT, DURING THR SURGERY, ONE (1) R3 LNR MPACTOR HD II 36 MM BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED, OR IF THERE WAS ANY DELAY. THE PATIENT¿S OUTCOME IS ALSO UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21532234 ↗MalfunctionOct 23, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR, ONE (1) R3 LNR MPACTOR HD II 36 MM CRACKED IN HALF DURING IMPACTION. ALL PIECES WERE RECOVERED. 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 20514968 ↗MalfunctionJan 30, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING THR SURGERY, AN R3 LNR MPACTOR HD II 36MM WAS BROKEN WHEN IMPACTING THE LINER. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, IT IS UNKNOW HOW. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18607756 ↗MalfunctionDec 19, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING THR SURGERY, AN R3 LNR MPACTOR HD II 36MM SPLIT IN TWO PIECES. 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 18359180 ↗MalfunctionAug 3, 2023Break; Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED THAT, DURING A THR SURGERY, AFTER CONSTANT IMPACTION OF THE R3 LNR MPACTOR HD II 36MM IT BROKE IN FRAGMENTS. ALL PIECES WERE REMOVED WITH PICK-UPS/TWEEZERS. 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 17455579 ↗MalfunctionMay 25, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING USE, A R3 LNR MPACTOR HD II 36MM CRACKED UPON IMPACTION. HAS A PIECE BREAK OFF. IT IS UNKNOWN HOW WAS THE SURGERY COMPLETED AND IF A DELAY WAS PRESENTED. 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 17004082 ↗MalfunctionDec 6, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR PROCEDURE, THE R3 LNR MPACTOR HD II 36MM BROKE UPON IMPACTION. AT THIS TIME, IT IS UNKNOWN IF PIECES FELL INTO THE PATIENT. IT WAS UNSPECIFIED HOW THE PROCEDURE WAS COMPLETED. NO DELAYS OR INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15923686 ↗MalfunctionOct 12, 2022Break; Break
IT WAS REPORTED THAT, TWO (2) R3 LNR MPACTOR HD II 36MM ARE BROKEN. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15592147 ↗MalfunctionOct 12, 2022Fracture; Fracture
IT WAS REPORTED THAT TWO (2) R3 LNR MPACTOR HD II 36MM ARE BROKEN. AS THIS WAS NOTICED DURING FIELD INSPECTION, NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15591447 ↗MalfunctionSep 22, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING A THR SURGERY THE R3 LNR MPACTOR HD II 36MM CRACKED UPON IMPACTION. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK UP DEVICE. NO FURTHER COMPLICATION WAS REPORTED. AFTER VISUAL INSPECTION OF THE DEVICE, IT WAS FOUND THAT THE DEVICE IS FRACTURED RENDERING THE DEVICE INOPERATIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15466368 ↗InjuryAug 23, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP OF A R3 LNR MPACTOR HD II 36MM BROKE WHEN IMPACTING THE LINER. ALL BROKEN PIECES WERE REMOVED FROM BODY AND LINER WAS SET APPROPRIATELY. SURGERY WAS FINISHED WITHOUT ANY DELAY. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15280040 ↗MalfunctionMay 31, 2022Break; Break
IT WAS REPORTED THAT, DURING A THR SURGERY, AN R3 LNR MPACTOR HD II 36MM BROKE OUTSIDE OF THE PATIENT, AND NO PIECES FELL INSIDE OF 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 14549302 ↗MalfunctionMay 11, 2022Break; Break
IT WAS REPORTED THAT, WHILE RESETTING TRAYS, A R3 LNR MPACTOR HD II 36 MM WAS BROKEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14352646 ↗MalfunctionMay 9, 2022Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF A R3 LNR MPACTOR HD II 36 MM BROKE WHEN RESETTING TRAYS. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14342619 ↗MalfunctionMay 6, 2022Crack; Fracture; Crack; Fracture
IT WAS REPORTED THAT, DURING THR SURGERY, A R3 LNR MPACTOR HD II 36MM CRACKED. NO SURGICAL DELAY WAS REPORTED TO OCCUR, AS A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE TO CONCLUDE THE PROCEDURE. THE PATIENT WAS NOT HARMED DUE TO THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14307653 ↗MalfunctionApr 22, 2022Break; Break
IT WAS REPORTED THAT, DURING A THR SURGERY, A R3 LNR MPACTOR HD II 36MM BROKE UPON IMPACT. NO PIECES FELL INTO THE PATIENT. SURGERY WAS FINISHED, 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 14181851 ↗MalfunctionMar 26, 2022Break; Break
IT WAS REPORTED THAT THE R3 LNR MPACTOR HD II 36MM WAS DISCOVERED BROKE AFTER CLEANING, WHEN SET WAS BEING PUT BACK TOGETHER. NO CASE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13925085 ↗MalfunctionMar 16, 2022Crack; Crack
IT WAS REPORTED THAT, PRIOR TO TOTAL HIP REPLACEMENT, THE TIP OF AN R3 LINER IMPACTOR HEAD II 36MM WAS NOTICED TO BE CRACKED. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, USING A SMITH & NEPHEW BACK-UP DEVICE INSTEAD. SINCE INCIDENT OCCURRED BEFORE PROCEDURE, PATIENT WAS NOT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13778584 ↗
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 · TerminatedSL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
- Z-1008-2017 · Nov 16, 2016 · TerminatedREFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
Other Prosthesis, hip, femoral component, cemented, metal devices
- GENESIS II 71440005Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal599 reports
- NA 71364073Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal436 reports
- Peri-Loc 71173377Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal401 reports
- R3 71368569Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal398 reports
- NA 71364006Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal197 reports
- NA 71364011Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal176 reports
- Accord 71360046Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal171 reports
- REFLECTION 71362279Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal155 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.