HarmonyRecalls & reported problems across all models
Smith & Nephew, Inc. · 25 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 321
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls
- 0
We found 25 models of Harmony by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 321 adverse event reports in the FDA's MAUDE database, received between May 6, 2021 and Jul 14, 2026 — classified as 19 injuries, 302 malfunctions.
The most frequently reported specific device problem is “Fracture” (240 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 Harmony problems
Device problems
- Fracture240
- Break74
- Material Fragmentation6
- Crack3
- Detachment of Device or Device Component2
- Separation Failure2
- Defective Device1
- Difficult to Insert1
Patient problems
- No Clinical Signs, Symptoms or Conditions305
- Device Embedded In Tissue or Plaque8
- Foreign Body In Patient6
- Insufficient Information5
- Perforation1
Harmony models
25 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Harmony 74016249IMPACTOR52 reports
- Harmony 74016262ORTHOPEDIC MANUAL SURGICAL INSTRUMENT50 reports
- Harmony 74016250IMPACTOR49 reports
- Harmony 74016264ORTHOPEDIC MANUAL SURGICAL INSTRUMENT40 reports
- Harmony 74016252IMPACTOR38 reports
- Harmony 74016465PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER22 reports
- Harmony 74016260ORTHOPEDIC MANUAL SURGICAL INSTRUMENT17 reports
- Harmony 74016255ORTHOPEDIC MANUAL SURGICAL INSTRUMENT9 reports
- Harmony 74016263ORTHOPEDIC MANUAL SURGICAL INSTRUMENT9 reports
- Harmony 74016265ORTHOPEDIC MANUAL SURGICAL INSTRUMENT9 reports
- Harmony 74016266ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6 reports
- Harmony 74016205ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- Harmony 74016257ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- Harmony 74016261Trousers, anti-shock2 reports
- Harmony 74016268IMPACTOR2 reports
- Harmony 74033813TEMPLATE1 report
- Harmony 74016461DRIVER, PROSTHESIS1 report
- Harmony 74016464PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Harmony 74016203ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Harmony 74016216ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Harmony 74016217ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Harmony 74016232ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Harmony 74016241ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Harmony 74016259ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Harmony 74016267ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent Harmony adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25818258 ↗MalfunctionJun 7, 2026Break
IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 11MM BROKE. NOTHING FELT INTO THE PATIENT. 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 25422699 ↗MalfunctionJun 4, 2026Fracture
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGERY, ONE (1) MIS 3.2 MM X 45 MM RIMMED STERILE PIN BROKE IN THE FEMUR. THE SURGEON WAS ABLE TO REMOVE THE BROKEN PIN. THE KNEE ARTHROPLASTY WAS RESUMED WITHOUT ANY DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25402746 ↗MalfunctionJun 1, 2026Fracture; Premature Separation
IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN TRIALING ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 11MM, THE SPACER BECAME UNCOUPLED FROM THE TRIAL INSERT, IT THEN WEDGED BETWEEN THE TRIAL FEMUR AND TRIAL TIBIA BASE PLATE AND BROKE INTO A FEW PIECES. PIECES WERE RETRIEVED FROM WOUND WITH A TONSIL. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED. THERE ARE NO OPERATIVE NOTES OR SURGICAL REPORTS AVAILABLE. THERE IS NO LOT NUMBER SINCE DEVICE WAS THROWN AWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25354224 ↗MalfunctionMay 31, 2026Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 11MM BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; HOWEVER, THERE WAS NO DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25345417 ↗MalfunctionMay 31, 2026Break
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PLASTIC JUNCTION OF ONE (1) MODULAR UNIVERSAL TIBIAL IMPACTOR BROKE. 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 25342866 ↗MalfunctionMay 18, 2026Break
IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) MIS 3.2MM X 45MM RIMMED PIN STERILE BROKE INTRAOPERATIVELY. NO PIECES FELL INTO PATIENT. 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 25211633 ↗MalfunctionMay 15, 2026Fracture
IT WAS REPORTED THAT, DURING A TOTAL KNEE SURGERY, THE BASE OF THE POST OF ONE (1) MODULAR UNIVERSAL TIBIAL IMPACTOR FRACTURED WHEN IMPACTING THE TIBIA BASEPLATE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE USING A FEMORAL IMPACTOR. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25187443 ↗MalfunctionMay 8, 2026Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 11MM FRACTURED. NO FRAGMENTS IN THE PATIENT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICES. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25131077 ↗MalfunctionApr 30, 2026Fracture
IT WAS REPORTED THAT, DURING A TKA, ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 11MM BROKE IN HALF. THE TWO PIECES WERE DISPOSED OF PROPERLY BY HOSPITAL STAFF. NO PART WAS LEFT IN THE PATIENT¿S ANATOMY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED AND PATIENT LEFT SURGERY IN GOOD HEALTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25049354 ↗MalfunctionApr 28, 2026Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 11MM BROKE WHEN TRIALING. 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 25017825 ↗MalfunctionApr 20, 2026Fracture
IT WAS REPORTED THAT DURING A TKA SURGERY, THE JOURNEY LOCKING TIBIAL IMPACTOR BROKE IN HALF. IT DID NOT FALL INTO THE WOUND. PIECES RETRIEVED BY HAND. 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 24924274 ↗MalfunctionApr 10, 2026Break
IT WAS REPORTED THAT, DURING A TKA, AN UNIVERSAL INSERT SPACER SZ 5-6 11MM BROKE. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. 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 24845450 ↗MalfunctionApr 5, 2026Break
IT WAS REPORTED THAT, DURING A TKA, A UNIVERSAL INSERT SPACER SZ 5-6 11MM BROKE. 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 24787086 ↗MalfunctionApr 5, 2026Break
IT WAS REPORTED THAT, DURING A KNEE PROCEDURE, A UNIVERSAL INSERT SPACER SZ 7-8 11MM BROKE. 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 24786973 ↗
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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