ORTHOMATCH 71442132Recalls & reported problems
Smith & Nephew, Inc. · ORTHOMATCH ANKLE CLAMP · Class 2
All models of ORTHOMATCH (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556496503), received between Mar 10, 2022 and Feb 20, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 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
- Fracture3
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN TRYING TO PLACE THE TIBIAL GUIDE IN THE PATIENT, ONE (1) ORTHOMATCH ANKLE CLAMP BROKE AND ONE (1) FEMORAL IMPLANT IMPACTOR BROKE WHEN IMPACTING THE FEMORAL COMPONENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING S+N BACK-UP DEVICES. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21420114 ↗MalfunctionJan 18, 2024Break; Break
IT WAS REPORTED THAT DURING A TKA SURGERY THE ORTHOMATCH ANKLE CLAMP BROKE INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18540357 ↗MalfunctionJun 14, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) ORTHOMATCH ANKLE CLAMP BROKE WHEN OPENING THE CLIP TO FIT IT TO THE PATIENT'S ANKLE. THE GENESIS TIBIA GUIDE WAS USED TO CUT THE TIBIA. 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 17132235 ↗MalfunctionDec 5, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, AN ORTHOMATCH ANKLE CLAMP BROKE. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15921732 ↗MalfunctionMar 10, 2022Break; Break
IT WAS REPORTED THAT, DURING A TKA SURGERY, A ORTHOMATCH ANKLE CLAMP BROKE. NO BROKEN PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13722681 ↗
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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