Viant Medical, LLC 511172Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00840096400045), received between Jan 28, 2020 and Feb 13, 2026 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (11 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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2026Loss of or Failure to Bond; Break; Material Integrity Problem; No Apparent Adverse Event

  IT WAS REPORTED DURING A TOTAL HIP REPLACEMENT THAT THE WELD ON THE HANDLE HAS BROKEN CAUSING THE HANDLE TO UNSCREW AND NOT BE FUNCTIONAL. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 24339034 ↗
• MalfunctionAug 7, 2025Mechanical Problem; Device Slipped; Unintended Movement; Mechanical Problem; Device Slipped; Unintended Movement

  IT WAS REPORTED DURING A THA SURGERY FOR OA ON HIP JOINT ON AN UNKNOWN PATIENT THAT A CUP LOCKING PROBLEM OCCURRED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH MORE THAN 30 MINUTES SURGICAL DELAY. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22741808 ↗
• MalfunctionMar 12, 2025Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam

  IT WAS REPORTED DURING AN UNKNOWN PROCEDURE ON A MALE PATIENT THAT THE KNOB ON CUP INSERTER IS STIFF WHICH MAKING THE RELEASE OF THE CUP DIFFICULT AFTER IMPACTING. THERE WAS NO SURGICAL DELAY AND NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21584661 ↗
• MalfunctionNov 1, 2024Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam

  IT WAS REPORTED DURING AN UNKNOWN PROCEDURE ON A MALE PATIENT THAT THE HANDLE WOULDN'T DISENGAGE FROM THE CUP ONCE THE CUP WAS PLACED. NO KNOWN DELAY AND CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 20592524 ↗
• MalfunctionOct 4, 2024Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam

  IT WAS REPORTED DURING AN UNKNOWN PROCEDURE ON A MALE PATIENT THAT THE PIECE THAT TIGHTENS ONTO THE OFFSET IMPACTOR TO CONNECT THE CUP WOULD NOT COME LOOSE TO TAKE THE HANDLE OFF THE CUP. NO KNOWN DELAY AND CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 20375212 ↗
• MalfunctionMar 28, 2024Mechanical Problem; Mechanical Jam; Damaged Thread; Mechanical Problem; Mechanical Jam; Damaged Thread

  IT WAS REPORTED DURING A HIP SURGERY ON AN UNKNOWN PATIENT THAT THE OFFSET CUP IMPACTOR THREADS ARE DAMAGED. IT WILL NOT RELEASE THE CUP AFTER IMPACTION / INSERTION AND RISKS THE CUP MOVING FROM OPTIMAL POSITIONING. THE SURGEON TOOK THEIR TIME TO REMOVE THE CUP FROM THE IMPACTOR RESULTING IN A FIVE (5) MINUTE DELAY IN SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18999357 ↗
• MalfunctionMar 14, 2024Break; Material Deformation; Material Twisted/Bent; Mechanical Jam; Break; Material Deformation; Material Twisted/Bent; Mechanical Jam

  IT WAS REPORTED DURING A THA (TOTAL HIP ARTHROPLASTY) FOR OA (OSTEOARTHRITIS) OF THE HIP JOINT ON A 74 YEAR OLD FEMALE PATIENT THAT THE SURGEON ATTACHED THE CUP TO THE PRODUCT AND STRUCK IT. WHEN THE SCREW WAS TURNED TO REMOVE THE CUP FROM THE PRODUCT, THE SCREW DID NOT MOVE. SINCE THE SCREW WOULD NOT MOVE, THE SURGEON PULLED THE CUP OUT OF ACETABULUM TO CHECK IT AND FOUND THAT THE METAL AT THE JOINT WAS DEFORMED. THE DEFORMED AREA WAS SPREAD OUTWARD AND COULD NOT BE USED. ANOTHER SIMILAR PRODUCT (STRAIGHT IMPACTOR) WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH SURGERY TIME EXTENDED BY ABOUT 10 MINUTES. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18906249 ↗
• MalfunctionSep 19, 2023Failure to Disconnect; Mechanical Jam; Failure to Disconnect; Mechanical Jam

  IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT THE IMPACTOR WAS DIFFICULT TO REMOVED/UNSCREW FROM THE IMPLANT. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17775756 ↗
• MalfunctionSep 19, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED DURING A TOTAL HIP REPLACEMENT THAT WHEN IMPACTING THE BACK OF THE HANDLE, THE DRIVE SHAFT THAT SCREWS INTO THE CUP SHEARED. A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH THE SAME IMPLANT SINCE IT WAS NOT SEATED IN THE PATIENT YET. THERE WAS A DELAY OF A COUPLE MINUTES TO GET AND OPEN ANOTHER TRAY, BUT THERE WERE NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17775751 ↗
• MalfunctionJul 5, 2023Failure to Disconnect; Mechanical Jam; Failure to Disconnect; Mechanical Jam

  IT WAS REPORTED DURING A TOTAL HIP REPLACEMENT THAT THE OFFSET CUP INSERTER WAS DIFFICULT TO REMOVE FROM THE ACETABULAR COMPONENT AFTER IMPACTION. IT IS UNKNOWN IF THERE WERE ANY HEALTH CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17260159 ↗
• MalfunctionJul 5, 2023Failure to Disconnect; Mechanical Jam; Failure to Disconnect; Mechanical Jam

  IT WAS REPORTED DURING A TOTAL HIP REPLACEMENT THAT IT IS DIFFICULT TO REMOVE CUP FROM OFFSET IMPACTOR AFTER IMPLANTING. IT IS UNKNOWN IF THERE WERE ANY HEALTH CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17259688 ↗
• MalfunctionJul 5, 2023Failure to Disconnect; Mechanical Jam; Failure to Disconnect; Mechanical Jam

  IT WAS REPORTED DURING A TOTAL HIP REPLACEMENT THAT THE ACETABULAR COMPONENT DIFFICULT TO REMOVE AFTER IMPACTION. IT IS UNKNOWN IF THERE WERE ANY HEALTH CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17256419 ↗
• MalfunctionJun 23, 2023Failure to Disconnect; Mechanical Jam; Failure to Disconnect; Mechanical Jam

  IT WAS REPORTED DURING TOTAL HIP REPLACEMENT ON AN UNKNOWN PATIENT PROCEDURE THAT THE OFFSET CUP INSERTER GETS STUCK ON THE REAL IMPLANT AND IT'S VERY DIFFICULT TO UNSCREW. THERE WAS A SURGICAL DELAY OF 10 SECONDS TO GET PLIERS TO HELP LOOSEN THE DEVICE DUE TO THE REPORTED MALFUNCTION. THERE WERE NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17195244 ↗
• MalfunctionJun 15, 2023Failure to Disconnect; Mechanical Jam; Failure to Disconnect; Mechanical Jam

  IT WAS REPORTED DURING AN UNKNOWN PROCEDURE THAT THE CURVED CUP INSERTER IS CROSS THREADED. THE CUP WOULD NOT DISENGAGE FROM THE INSERTER. THE CUP WAS PULLED OUT AND REMOVED, AND PUT ON A STRAIGHT HANDLE FOR INSERTION. IT IS UNKNOWN IF THERE WERE ANY HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 17140085 ↗
• MalfunctionJan 28, 2020Break; Break

  IT WAS REPORTED THAT THE LATCH BROKE ON OFFSET CUP IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9636362 ↗