ORTHOMATCH 71442193Recalls & reported problems
Smith & Nephew, Inc. · ORTHOMATCH MODULAR POSTERIOR STABILIZED FEMORAL IMPLANT IMPACTOR · Class 2
All models of ORTHOMATCH (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Smith & Nephew OrthoMatch femoral impactor is a surgical instrument used to hammer knee implants into place during total knee replacement. The 64 reports mostly describe the instrument cracking or breaking apart while being struck during surgery, sometimes leaving a piece inside the wound that had to be pulled out with forceps. There are 7 injuries and no deaths, and 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
- 62
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00885556583784), received between Aug 31, 2018 and Jun 12, 2026 — classified as 7 injuries, 55 malfunctions.
The most frequently reported specific device problem is “Break” (31 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
- Break31
- Fracture31
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions44
- No Consequences Or Impact To Patient13
- No Known Impact Or Consequence To Patient4
- Foreign Body In Patient1
- Injury1
- No Code Available1
Recent adverse event reports
The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2026Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR FRACTURED UPON IMPACTION WITH THE DEFINITIVE FEMORAL IMPLANT. 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 25494392 ↗MalfunctionMay 31, 2026Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR WAS FRACTURED. 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 25342369 ↗MalfunctionMar 20, 2026Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR USED TO HAMMER THE FINAL FEMORAL IMPLANT BROKE IN HALF. IT WAS REMOVED FROM INSIDE THE PATIENT USING FORCEPS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24649645 ↗MalfunctionFeb 18, 2026Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE END STOP OF ONE (1) ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR BROKE DURING THE FIXATION OF THE FEMORAL IMPLANT. THIS DID NOT IMPACT THE FINAL SURGICAL PROCEDURE AS IT REMAINED WELL FIXED. NO HARM TO THE PATIENT WAS REPORTED. 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 24376861 ↗MalfunctionDec 3, 2025Break; Break
IT WAS REPORTED THAT DURING A TKR SURGERY, WHILE THE DEFINITIVE FEMUR WAS BEING IMPACTED, ONE (1) ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR BROKE. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23705318 ↗MalfunctionDec 1, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A KNEE REPLACEMENT PROCEDURE, THE ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR BROKE AS THE DOCTOR WAS FINISHING THE FEMUR. NO HARM TO THE PATIENT WAS REPORTED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23687445 ↗MalfunctionAug 26, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING TKA SURGERY ONE (1) ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR BROKE AFTER ATTEMPTED TO IMPACT THE DEFINITIVE FEMORAL COMPONENT. THE PROCEDURE WAS COMPLETED WITHOUT 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 22900995 ↗MalfunctionAug 4, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA SURGERY, THE ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR BROKE WHILE IMPACTING THE FEMORAL IMPLANT. NO PIECES FELL INTO THE INCISION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. NO DAMAGE WAS CAUSED; THE PATIENT'S HEALTH CONDITION IS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22710609 ↗MalfunctionJul 9, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY ONE (1) ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR BROKE WHILE IMPACTING THE DEFINITIVE PROSTHESIS. 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 22465364 ↗MalfunctionJun 11, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN THE FEMORAL COMPONENT WAS IMPACTED ONE (1) ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR BROKE. IT IS UNKNOWN HOW THE PROCEDURE FINISHED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22185658 ↗MalfunctionMay 28, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR FRACTURED EXTERNAL TO PATIENT. 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 22101468 ↗MalfunctionApr 10, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA SURGERY, WHEN IMPACTING THE FEMORAL PROSTHESIS, THE ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR BROKE ON THE FIRST HIT WITH THE HAMMER. NO PIECES FELL INTO PATIENT. THERE WAS NO 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 21815930 ↗MalfunctionNov 7, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING TKA SURGERY, ONE (X1) ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR BROKE. THE PROCEDURE WAS COMPLETED WITHOUT 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 20631388 ↗MalfunctionSep 16, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY, WHEN THE FINAL BLOW WAS MADE WITH THE ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR TO IMPACT THE IMPLANT, THE IMPACTOR BROKE. 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 20225494 ↗MalfunctionAug 12, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA, AT THE END WHEN IMPACTING THE FEMORAL COMPONENT THE ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR BROKE. THE MATERIAL WAS DAMAGED INSIDE THE PATIENT, HOWEVER, NO FRAGMENTS OF THE MATERIAL REMAINED INSIDE THE PATIENT, THERE WERE COMPLETELY REMOVED. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO HARM TO PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19961297 ↗MalfunctionJul 11, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN IMPACTING THE FEMORAL COMPONENT IMPLANT, THE POST OF A ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR BROKE. 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 19727237 ↗MalfunctionApr 26, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA, ONE (1) ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR BROKE WHEN FIXING THE FEMORAL IMPLANT. AND ONE (1) PATELLA RESECTION GUIDE DISASSEMBLED IN THE DOCTOR'S HAND AFTER CUTTING THE PATELLA. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME IMPACTOR. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19197572 ↗MalfunctionFeb 23, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA SURGERY, THE ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR FRACTURED WHEN IMPACTED WITH THE HAMMER. THE PROCEDURE WAS RESUMED, 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 18773343 ↗MalfunctionFeb 2, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING TOTAL KNEE ARTHROPLASTY SURGERY, WHEN IMPACTING THE FEMORAL IMPLANT, TWO (2) ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18636431 ↗MalfunctionDec 26, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA IN THE FIXATION OF THE IMPLANTS A ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR BROKE. 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 18392591 ↗MalfunctionNov 16, 2023Break; Break
IT WAS REPORTED THAT DURING TKA SURGERY, AN ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR BROKE. SURGERY WAS RESUMED WITHOUT ANY DELAY WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THE PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18150475 ↗MalfunctionNov 16, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING TKA SURGERY, AN ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. IT IS UNKNOWN IF BROKEN PIECES FELL INTO THE PATIENT. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18149404 ↗MalfunctionNov 13, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING TKA SURGERY, AN ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR BROKE IN TWO PIECES WHEN THE IMPLANT WAS BEING CEMENTED, ANY PIECE FELL INSIDE THE WOUND, ALL THE BROKEN PIECES WERE ACCOUNTED AND REMOVED WITH TWEEZERS. 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 18119757 ↗MalfunctionNov 8, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA PROCEDURE, WHEN IMPACTING THE FEMORAL COMPONENT, THE ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR BROKE INTO TWO PARTS, MAKING IT IMPOSSIBLE TO USE. SURGEON REMOVED THE PIECES. 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 18097874 ↗MalfunctionSep 14, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA, WHILE IMPACTING THE DEFINITIVE FEMORAL COMPONENT, A ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR BROKE. HOWEVER NO PIECES FELL INSIDE THE PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY 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 17744538 ↗
Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices
- ATTUNE 1506-00-005Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER589 reports
- ATTUNE 1506-00-004Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER580 reports
- JOURNEY 74012812Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER502 reports
- JOURNEY 74011856Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER438 reports
- PERSONA™ 42-5099-094-00Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER406 reports
- JOURNEY 74011857Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER388 reports
- ATTUNE 1506-00-007Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER288 reports
- ATTUNE 1506-00-003Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER271 reports
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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