ORTHOMATCHRecalls & reported problems across all models
Smith & Nephew, Inc. · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 163
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls
- 0
We found 10 models of ORTHOMATCH by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 163 adverse event reports in the FDA's MAUDE database, received between Dec 6, 2017 and Jun 12, 2026 — classified as 22 injuries, 141 malfunctions.
The most frequently reported specific device problem is “Break” (94 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ORTHOMATCH problems
Device problems
- Break94
- Fracture59
- Crack3
- Material Deformation3
- Detachment of Device or Device Component2
- Adverse Event Without Identified Device or Use Problem1
- Connection Problem1
- Degraded1
Patient problems
- No Clinical Signs, Symptoms or Conditions116
- No Consequences Or Impact To Patient24
- No Known Impact Or Consequence To Patient14
- No Information5
- Injury3
- No Code Available2
- Foreign Body In Patient1
- Laceration(s)1
ORTHOMATCH models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ORTHOMATCH 71442193PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER62 reports
- Orthomatch 71436399PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER35 reports
- ORTHOMATCH 71442161PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER20 reports
- ORTHOMATCH 71442165PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER14 reports
- ORTHOMATCH 71442109PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER11 reports
- ORTHOMATCH 71442171PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- ORTHOMATCH 71442132PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- ORTHOMATCH 71442162PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- ORTHOMATCH 71442194PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- ORTHOMATCH 71442401PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
Recent ORTHOMATCH adverse event reports
The 15 most recent reports across all models, 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 RIGHT TKA SURGERY, AT THE MOMENT OF FINAL IMPACT OF THE FEMORAL IMPLANT, AFTER CEMENTATION, A PART OF THE ORTHOMATCH CR IMPLANT IMPACTOR BROKE. NO PIECES FELL INSIDE THE PATIENT. 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 24379500 ↗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 23, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, WHILE REMOVING ONE (1) ORTHOMATCH FEMORAL SIZER THE PIN THREAD BROKE. THE BROKEN PIECE WAS RETRIEVED USING FORCEPS. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23879077 ↗MalfunctionDec 18, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING A TKA SURGERY, THE CUTTING BLOCK HAD A SPACE WHERE THE SAW PASSES THAT WAS TOO LARGE, MAKING A PERFECT CUT DIFFICULT. A RISK OF INJURY TO THE PATIENT WAS REPORTED, AS THE EXCESSIVE OPENING COULD HAVE CAUSED AN IMPERFECT CUT. 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 23843504 ↗MalfunctionDec 18, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, DURING IMPACTION ONE (1) ORTHOMATCH MOD FEM TRIAL IMPACTOR BROKE , WHICH LED TO A SMALL FRAGMENT FALLING INTO THE WOUND. THE FRAGMENT WAS REMOVED WITH FORCEPS AND THE INSTRUMENT WAS CONTINUED TO BE IMPACTED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT CURRENT HEALTH STATUS IS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23838173 ↗MalfunctionDec 16, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, AT THE TIME OF IMPACTING THE COMPONENT WITH ONE (1), ORTHOMATCH CR IMPLANT IMPACTOR BROKE INSIDE THE PATIENT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT ORTHOMATCH CR IMPLANT IMPACTOR BACK UP AND WITH THE SAME ORTHOMATCH MOD FEM TRIAL IMPACTOR. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23816512 ↗MalfunctionDec 16, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) ORTHOMATCH MOD FEM TRIAL IMPACTOR BROKE UPON IMPACT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT ORTHOMATCH CR IMPLANT IMPACTOR BACK UP AND WITH THE SAME ORTHOMATCH MOD FEM TRIAL IMPACTOR. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23816361 ↗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 ↗MalfunctionNov 3, 2025Break; Break
IT WAS REPORTED THAT, DURING A KNEE REPLACEMENT PROCEDURE, THE ORTHOMATCH TIB-INSERT IMPLANT IMPACTOR BROKE WHILE IMPACTING THE FINAL TIBIAL BASE. THE FEMORAL IMPACTOR WAS USED TO COMPLETE THE PROCEDURE. 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 23460449 ↗MalfunctionSep 9, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA SURGERY, AT THE TIME OF IMPACTING THE FEMUR DURING CEMENTING, THE ORTHOMATCH CR IMPLANT IMPACTOR BROKE OFF. THE PROCEDURE WAS RESUMED WITHOUT SURGICAL DELAY USING THE SAME DEVICE. THE PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23000291 ↗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 ↗
Other Smith & Nephew, Inc. products
- FAST-FIX18 models · 9,554 reports
- JOURNEY566 models · 6,250 reports · 4 recalls
- GENESIS II462 models · 4,599 reports · 2 recalls
- DYONICS, POWERMAX, ELITE2 models · 4,308 reports
- TRIGEN381 models · 3,599 reports · 5 recalls
- LEGION446 models · 2,039 reports · 4 recalls
- REAL INTELLIGENCE32 models · 2,017 reports · 3 recalls
- Coblation62 models · 2,126 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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