PROFIXRecalls & reported problems across all models
Smith & Nephew, Inc. · 22 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 85
- Deaths reported
- 0
- Injuries reported
- 65
- Recalls
- 0
We found 22 models of PROFIX by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 85 adverse event reports in the FDA's MAUDE database, received between Apr 18, 2017 and Apr 16, 2026 — classified as 65 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Defective Component” (28 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 PROFIX problems
Device problems
- Defective Component28
- Insufficient Device Problem Information17
- Fracture14
- Loose or Intermittent Connection9
- Adverse Event Without Identified Device or Use Problem7
- Break6
- Failure to Osseointegrate2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Consequences Or Impact To Patient30
- Pain18
- No Clinical Signs, Symptoms or Conditions15
- No Information8
- No Known Impact Or Consequence To Patient4
- Arthralgia2
- Failure of Implant2
- Foreign Body In Patient2
PROFIX models
22 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PROFIX 71512452ORTHOPEDIC MANUAL SURGICAL INSTRUMENT42 reports
- PROFIX 71501010PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- PROFIX 71504320PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- PROFIX 71504325PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- PROFIX 71512478ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- PROFIX 71504260PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- PROFIX 71507251PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- PROFIX 71507261PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- PROFIX 71512449PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- PROFIX 71512040PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- PROFIX 71502160PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- PROFIX 71502220PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- PROFIX 71502260PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- PROFIX 71504160PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- PROFIX 71507152PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- PROFIX 71508121PROSTHESIS, TOE, CONSTRAINED, POLYMER1 report
- PROFIX 71512455PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- PROFIX 71524150PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- PROFIX 71524220PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- PROFIX 71524240PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- PROFIX 71514630Prosthesis, hip, femoral component, cemented, metal1 report
- PROFIX 71503250PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
Recent PROFIX adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED IN 2003, THE PATIENT DEVELOPED A PROSTHETIC JOINT INFECTION. A REVISION SURGERY WAS CARRIED ON (B)(6) 2026 TO ADDRESS THIS EVENT, PERFORMING A WASHOUT INSERT EXCHANGE. ONLY THE PRO CONF TB ISRT LT S5 10 WAS REMOVED AND REPLACED, ALL OTHER COMPONENT REMAINED INTACT. NO FURTHER DETAILS ARE AVAILABLE AT THE MOMENT.
Patient problems: Medical device site infection
MAUDE report 24898121 ↗InjuryApr 1, 2026Device Fell
IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) PRO BONE SPIKE-SHORT FELL INTO THE FEMORAL CANAL DURING A SURGICAL PROCEDURE WHILE REMOVING THE PIN THAT FIXES THE TRIAL TIBIAL PLATE, AND THE DEVICE COULD NOT BE EXTRACTED. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 24750701 ↗MalfunctionMar 30, 2026Fracture
IT WAS REPORTED THAT, DURING A HIP REPLACEMENT SURGERY, WHILE HAMMERING, A PIECE OF THE PROFIX 750 GRAMS MALLET FLEW OFF. NO DAMAGE CAUSED, THE PATIENT'S HEALTH CONDITION IS STABLE. NO PIECES FELL INTO THE PATIENT'S WOUND. 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 24724090 ↗MalfunctionJan 28, 2026Fracture
IT WAS REPORTED THAT, DURING A THA SURGERY WHILE THE CUP WAS BEING IMPACTED, THE POLYETHYLENE TIP OF ONE (1) PROFIX 750 GRAMS MALLET LOOSENED. THE DOCTOR CONTINUED HAMMERING, AND THE TIP FRACTURED. IT WAS CONFIRMED THAT NO FRAGMENTS FELL INSIDE THE WOUND. THE PROCEDURE HAD BEEN COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24199411 ↗MalfunctionJan 5, 2026Fracture; Insufficient Device Problem Information
IT WAS REPORTED THAT, DURING A THR SURGERY, THE PRO MALLET RPLCMNT HD WAS FAULTY. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH THE SAME REPORTED DEVICE. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23955930 ↗MalfunctionOct 6, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, WHILE USING THE METAL SIDE OF ONE (1) PRO MALLET RPLCMNT HD THE PLASTIC END BROKE OFF. THE BROKEN PIECE FELL ON THE FLOOR AND NOT IN THE PATIENT WOUND. NO FRAGMENTS IN THE WOUND. 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 23229324 ↗MalfunctionFeb 7, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING THR SURGERY, UPON IMPACTION OF THE FEMORAL RASPS, THE PLASTIC PART OF ONE (1) PRO MALLET RPLCMNT HD FRACTURED AND CAME LOOSE FROM THE HANDLE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21340011 ↗InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A TKA REVISION SURGERY, WHEN REMOVING THE PRO BONE SPIKE-SHORT FROM THE TIBIA MEASUREMENT, IT FELL INTO THE BONE CAVITY AND WAS NOT POSSIBLE TO REMOVE. SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS NOT HARMED DUE TO THIS EVENT.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 18927188 ↗MalfunctionFeb 19, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING THR SURGERY ON THE IMPACTION OF THE ACETABULAR CUP, IT WAS NOTICED THAT THE PLASTIC PART OF ONE (1) PROFIX 750 GRAMS MALLET BROKE INTO PIECES. THE PLASTIC PART WAS OUTSIDE THE PATIENT. 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 18730884 ↗MalfunctionFeb 17, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA SURGERY, THE PLASTIC END OF A PROFIX 750 GRAMS MALLET BROKE OFF WHEN IMPACTING METAL END. 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 18728262 ↗MalfunctionDec 26, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY, THE PLASTIC END OF A PROFIX 750 GRAMS MALLET BROKE OFF WHILE IMPACTING THE METAL END. 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 18393005 ↗MalfunctionDec 26, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY, THE PLASTIC END OF A PROFIX 750 GRAMS MALLET BROKE OFF WHILE IMPACTING THE METAL END. 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 18392990 ↗InjuryNov 30, 2023Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem; Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER RIGHT TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED PAIN. FURTHERMORE, X-RAYS ON (B)(6) 2023 SHOWED LUCENCY UNDER THE TIBIAL COMPONENTS PARTICULARLY IN THE PRO METAPH TIB STEM 18MM, THIS FINDINGS WOULD SUGGEST LOOSENING OF THE PROTHESES. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY PERFORMED ON (B)(6) 2023, IN WHICH A LGN POR HA TIB BASE W/O HOLES SZ 7 RT,LGN CR HIGH FLEX XLPE SZ 7-8 9MM AND A PRO METAPH TIB STEM 18MM WERE EXCHANGED. PATIENT AS FAR AS ACKNOWLEDGED IS FIT AND HEALTHY.
Patient problems: Arthralgia; Inadequate Osseointegration; Pain; Radiolucent Lines
MAUDE report 18238266 ↗InjuryNov 30, 2023Fracture; Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem; Fracture; Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER LEFT TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED PAIN. FURTHERMORE, X-RAYS ON (B)(6) 2023 SHOWED LUCENCY UNDER THE TIBIAL COMPONENT PARTICULARLY IN THE PRO METAPH TIB STEM 18MM, THIS FINDINGS WOULD SUGGEST LOOSENING OF THE PROTHESES. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY PERFORMED ON (B)(6) 2023, IN WHICH A LGN POR HA TIB BASE W/O HOLES SZ 7 LT, PRO METAPH TIB STEM 18MM AND A LGN CR HIGH FLEX XLPE SZ 7-8 9MM WERE EXCHANGED. PATIENT AS FAR AS ACKNOWLEDGED IS FIT AND HEALTHY.
Patient problems: Arthralgia; Inadequate Osseointegration; Pain; Radiolucent Lines
MAUDE report 18238074 ↗MalfunctionNov 28, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR, ONE (1) PROFIX 750 GRAMS MALLET FRACTURED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A COMPETITOR DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18221453 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page