PROFIX 71512452Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 03596010223890), received between Nov 1, 2018 and Mar 30, 2026 — classified as 28 injuries, 14 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionNov 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR A THE PLASTIC END BROKE OFF AND IT WAS STUCK IN A PROFIX 750 GRAMS MALLET. 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 18113941 ↗
• MalfunctionOct 23, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE PLASTIC TIP OF ONE (1) PROFIX 750 GRAMS MALLET BROKE. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17986277 ↗
• MalfunctionDec 29, 2020Crack; Crack

  IT WAS REPORTED THAT PROFIX 750 GRAMS MALLET WAS FOUND TO BE CRACKED AND GOUGED DURING A STANDARD EFIP INSPECTION. THERE WERE NO REPORTED PROBLEMS FROM ANY CASES AND NO CASE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11090306 ↗
• InjuryApr 13, 2020Defective Component; Defective Component

  IT WAS REPORTED THAT THE PLATFORM RECEIVED THE NOTICE OF BONE HAMMER DISINFECTION ISSUED BY THE COMPANY, AND THEN IT WAS STERILIZED IN STRICT ACCORDANCE WITH THE COMPANY'S REQUIREMENTS. THE POLYETHYLENE HEAD END OF BONE HAMMER WAS LOOSENED IN VARYING DEGREES AFTER SEVERAL TIMES OF DISASSEMBLY, AND IT COULD NOT BE USED NORMALLY DURING THE OPERATION. NO BACK UP WAS AVAILABLE AND A SIMILAR TOOLS FROM THE OPERATING ROOM OF THE HOSPITAL WAS BORROWED TO COMPLETE THE SURGERY. A LESS THAN 30 MIN DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9952334 ↗
• InjuryApr 7, 2020Defective Component; Defective Component

  IT WAS REPORTED THAT THE PLATFORM RECEIVED THE NOTICE OF BONE HAMMER DISINFECTION ISSUED BY THE COMPANY, AND THEN IT WAS STERILIZED IN STRICT ACCORDANCE WITH THE COMPANY'S REQUIREMENTS. THE POLYETHYLENE HEAD END OF BONE HAMMER WAS LOOSENED IN VARYING DEGREES AFTER SEVERAL TIMES OF DISASSEMBLY, AND IT COULD NOT BE USED NORMALLY DURING THE OPERATION. NO BACK UP WAS AVAILABLE AND A SIMILAR TOOL FROM THE OPERATING ROOM OF THE HOSPITAL WAS BORROWED TO COMPLETE THE SURGERY. A LESS THAN 30 MIN DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9932060 ↗
• InjuryApr 7, 2020Defective Component; Defective Component

  IT WAS REPORTED THAT THE PLATFORM RECEIVED THE NOTICE OF BONE HAMMER DISINFECTION ISSUED BY THE COMPANY, AND THEN IT WAS STERILIZED IN STRICT ACCORDANCE WITH THE COMPANY'S REQUIREMENTS. THE POLYETHYLENE HEAD END OF BONE HAMMER WAS LOOSENED IN VARYING DEGREES AFTER SEVERAL TIMES OF DISASSEMBLY, AND IT COULD NOT BE USED NORMALLY DURING THE OPERATION. NO BACK UP WAS AVAILABLE AND A SIMILAR TOOL FROM THE OPERATING ROOM OF THE HOSPITAL WAS BORROWED TO COMPLETE THE SURGERY. A LESS THAN 30 MIN DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9932059 ↗
• InjuryApr 7, 2020Defective Component; Defective Component

  IT WAS REPORTED THAT THE PLATFORM RECEIVED THE NOTICE OF BONE HAMMER DISINFECTION ISSUED BY THE COMPANY, AND THEN IT WAS STERILIZED IN STRICT ACCORDANCE WITH THE COMPANY'S REQUIREMENTS. THE POLYETHYLENE HEAD END OF BONE HAMMER WAS LOOSENED IN VARYING DEGREES AFTER SEVERAL TIMES OF DISASSEMBLY, AND IT COULD NOT BE USED NORMALLY DURING THE OPERATION. NO BACK UP WAS AVAILABLE AND A SIMILAR TOOL FROM THE OPERATING ROOM OF THE HOSPITAL WAS BORROWED TO COMPLETE THE SURGERY. A LESS THAN 30 MIN DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9932058 ↗
• InjuryApr 7, 2020Defective Component; Defective Component

  IT WAS REPORTED THAT THE PLATFORM RECEIVED THE NOTICE OF BONE HAMMER DISINFECTION ISSUED BY THE COMPANY, AND THEN IT WAS STERILIZED IN STRICT ACCORDANCE WITH THE COMPANY'S REQUIREMENTS. THE POLYETHYLENE HEAD END OF BONE HAMMER WAS LOOSENED IN VARYING DEGREES AFTER SEVERAL TIMES OF DISASSEMBLY, AND IT COULD NOT BE USED NORMALLY DURING THE OPERATION. NO BACK UP WAS AVAILABLE AND A SIMILAR TOOL FROM THE OPERATING ROOM OF THE HOSPITAL WAS BORROWED TO COMPLETE THE SURGERY. A LESS THAN 30 MIN DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9932057 ↗
• InjuryApr 7, 2020Defective Component; Defective Component

  IT WAS REPORTED THAT THE PLATFORM RECEIVED THE NOTICE OF BONE HAMMER DISINFECTION ISSUED BY THE COMPANY, AND THEN IT WAS STERILIZED IN STRICT ACCORDANCE WITH THE COMPANY'S REQUIREMENTS. THE POLYETHYLENE HEAD END OF BONE HAMMER WAS LOOSENED IN VARYING DEGREES AFTER SEVERAL TIMES OF DISASSEMBLY, AND IT COULD NOT BE USED NORMALLY DURING THE OPERATION. NO BACK UP WAS AVAILABLE AND A SIMILAR TOOL FROM THE OPERATING ROOM OF THE HOSPITAL WAS BORROWED TO COMPLETE THE SURGERY. A LESS THAN 30 MIN DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9932056 ↗
• InjuryApr 7, 2020Defective Component; Defective Component

  IT WAS REPORTED THAT THE PLATFORM RECEIVED THE NOTICE OF BONE HAMMER DISINFECTION ISSUED BY THE COMPANY, AND THEN IT WAS STERILIZED IN STRICT ACCORDANCE WITH THE COMPANY'S REQUIREMENTS. THE POLYETHYLENE HEAD END OF BONE HAMMER WAS LOOSENED IN VARYING DEGREES AFTER SEVERAL TIMES OF DISASSEMBLY, AND IT COULD NOT BE USED NORMALLY DURING THE OPERATION. NO BACK UP WAS AVAILABLE AND A SIMILAR TOOL FROM THE OPERATING ROOM OF THE HOSPITAL WAS BORROWED TO COMPLETE THE SURGERY. A LESS THAN 30 MIN DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9932055 ↗
• InjuryApr 7, 2020Defective Component; Defective Component

  IT WAS REPORTED THAT THE PLATFORM RECEIVED THE NOTICE OF BONE HAMMER DISINFECTION ISSUED BY THE COMPANY, AND THEN IT WAS STERILIZED IN STRICT ACCORDANCE WITH THE COMPANY'S REQUIREMENTS. THE POLYETHYLENE HEAD END OF BONE HAMMER WAS LOOSENED IN VARYING DEGREES AFTER SEVERAL TIMES OF DISASSEMBLY, AND IT COULD NOT BE USED NORMALLY DURING THE OPERATION. NO BACK UP WAS AVAILABLE AND A SIMILAR TOOL FROM THE OPERATING ROOM OF THE HOSPITAL WAS BORROWED TO COMPLETE THE SURGERY. A LESS THAN 30 MIN DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9932054 ↗
• InjuryApr 7, 2020Defective Component; Defective Component

  IT WAS REPORTED THAT THE PLATFORM RECEIVED THE NOTICE OF BONE HAMMER DISINFECTION ISSUED BY THE COMPANY, AND THEN IT WAS STERILIZED IN STRICT ACCORDANCE WITH THE COMPANY'S REQUIREMENTS. THE POLYETHYLENE HEAD END OF BONE HAMMER WAS LOOSENED IN VARYING DEGREES AFTER SEVERAL TIMES OF DISASSEMBLY, AND IT COULD NOT BE USED NORMALLY DURING THE OPERATION. NO BACK UP WAS AVAILABLE AND A SIMILAR TOOL FROM THE OPERATING ROOM OF THE HOSPITAL WAS BORROWED TO COMPLETE THE SURGERY. A LESS THAN 30 MIN DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9932053 ↗
• InjuryApr 7, 2020Defective Component; Defective Component

  IT WAS REPORTED THAT THE PLATFORM RECEIVED THE NOTICE OF BONE HAMMER DISINFECTION ISSUED BY THE COMPANY, AND THEN IT WAS STERILIZED IN STRICT ACCORDANCE WITH THE COMPANY'S REQUIREMENTS. THE POLYETHYLENE HEAD END OF BONE HAMMER WAS LOOSENED IN VARYING DEGREES AFTER SEVERAL TIMES OF DISASSEMBLY, AND IT COULD NOT BE USED NORMALLY DURING THE OPERATION. NO BACK UP WAS AVAILABLE AND A SIMILAR TOOL FROM THE OPERATING ROOM OF THE HOSPITAL WAS BORROWED TO COMPLETE THE SURGERY. A LESS THAN 30 MIN DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9932052 ↗
• InjuryApr 7, 2020Defective Component; Defective Component

  IT WAS REPORTED THAT THE PLATFORM RECEIVED THE NOTICE OF BONE HAMMER DISINFECTION ISSUED BY THE COMPANY, AND THEN IT WAS STERILIZED IN STRICT ACCORDANCE WITH THE COMPANY'S REQUIREMENTS. THE POLYETHYLENE HEAD END OF BONE HAMMER WAS LOOSENED IN VARYING DEGREES AFTER SEVERAL TIMES OF DISASSEMBLY, AND IT COULD NOT BE USED NORMALLY DURING THE OPERATION. NO BACK UP WAS AVAILABLE AND A SIMILAR TOOL FROM THE OPERATING ROOM OF THE HOSPITAL WAS BORROWED TO COMPLETE THE SURGERY. A LESS THAN 30 MIN DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9932051 ↗
• InjuryApr 7, 2020Defective Component; Defective Component

  IT WAS REPORTED THAT THE PLATFORM RECEIVED THE NOTICE OF BONE HAMMER DISINFECTION ISSUED BY THE COMPANY, AND THEN IT WAS STERILIZED IN STRICT ACCORDANCE WITH THE COMPANY'S REQUIREMENTS. THE POLYETHYLENE HEAD END OF BONE HAMMER WAS LOOSENED IN VARYING DEGREES AFTER SEVERAL TIMES OF DISASSEMBLY, AND IT COULD NOT BE USED NORMALLY DURING THE OPERATION. NO BACK UP WAS AVAILABLE AND A SIMILAR TOOL FROM THE OPERATING ROOM OF THE HOSPITAL WAS BORROWED TO COMPLETE THE SURGERY. A LESS THAN 30 MIN DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9932050 ↗
• InjuryApr 7, 2020Defective Component; Defective Component

  IT WAS REPORTED THAT THE PLATFORM RECEIVED THE NOTICE OF BONE HAMMER DISINFECTION ISSUED BY THE COMPANY, AND THEN IT WAS STERILIZED IN STRICT ACCORDANCE WITH THE COMPANY'S REQUIREMENTS. THE POLYETHYLENE HEAD END OF BONE HAMMER WAS LOOSENED IN VARYING DEGREES AFTER SEVERAL TIMES OF DISASSEMBLY, AND IT COULD NOT BE USED NORMALLY DURING THE OPERATION. NO BACK UP WAS AVAILABLE AND A SIMILAR TOOL FROM THE OPERATING ROOM OF THE HOSPITAL WAS BORROWED TO COMPLETE THE SURGERY. A LESS THAN 30 MIN DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9932048 ↗
• InjuryApr 7, 2020Defective Component; Defective Component

  IT WAS REPORTED THAT THE PLATFORM RECEIVED THE NOTICE OF BONE HAMMER DISINFECTION ISSUED BY THE COMPANY, AND THEN IT WAS STERILIZED IN STRICT ACCORDANCE WITH THE COMPANY'S REQUIREMENTS. THE POLYETHYLENE HEAD END OF BONE HAMMER WAS LOOSENED IN VARYING DEGREES AFTER SEVERAL TIMES OF DISASSEMBLY, AND IT COULD NOT BE USED NORMALLY DURING THE OPERATION. NO BACK UP WAS AVAILABLE AND A SIMILAR TOOL FROM THE OPERATING ROOM OF THE HOSPITAL WAS BORROWED TO COMPLETE THE SURGERY. A LESS THAN 30 MIN DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9932047 ↗
• InjuryApr 7, 2020Defective Component; Defective Component

  IT WAS REPORTED THAT THE PLATFORM RECEIVED THE NOTICE OF BONE HAMMER DISINFECTION ISSUED BY THE COMPANY, AND THEN IT WAS STERILIZED IN STRICT ACCORDANCE WITH THE COMPANY'S REQUIREMENTS. THE POLYETHYLENE HEAD END OF BONE HAMMER WAS LOOSENED IN VARYING DEGREES AFTER SEVERAL TIMES OF DISASSEMBLY, AND IT COULD NOT BE USED NORMALLY DURING THE OPERATION. NO BACK UP WAS AVAILABLE AND A SIMILAR TOOL FROM THE OPERATING ROOM OF THE HOSPITAL WAS BORROWED TO COMPLETE THE SURGERY. A LESS THAN 30 MIN DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9932046 ↗