V40 Head 6260-5-126Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327012859), received between Mar 20, 2019 and Mar 9, 2021 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2021Difficult to Insert; Device-Device Incompatibility; Difficult to Insert; Device-Device Incompatibility

  THE TAPER LOCK DID NOT WORK WHEN THE INNER HEAD IS ATTACHED. EVEN THOUGH IT WAS DRIVEN IN, IT CAN BE EASILY DETACHED BE HAND. SO ANOTHER PRODUCT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11445095 ↗
• MalfunctionJul 10, 2019Device Difficult to Setup or Prepare; Insufficient Device Problem Information; Device Difficult to Setup or Prepare; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A BHA, A HEAD DID NOT SLIDE SMOOTHLY ON THE SLIDING SURFACE OF THE REPORTED CENTRAX. SPARE HEAD AND CENTRAX WERE USED INSTEAD.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8775520 ↗
• InjuryMay 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE EXPLANTING OF BIPOLAR WAS PERFORMED DUE TO THE SUSPICION OF METAL ALLERGY. A LARGE AMOUNT OF LUMPY TISSUE EMERGED FROM THE HIP OF THE PATIENT. THE CUSTOMER WOULD LIKE TO KNOW THE AMOUNT OF POLYETHYLENE WEAR. EVENT UPDATE PER REVIEW OF THE CLINICIAN'S COMMENT: "REJECTED FOR MEDICAL REVIEW - SPACER NOTED ON X-RAY INDICATES INFECTION, HOWEVER, CANNOT CONFIRM INFECTION OR REPORTED EVENT.

  Patient problems: Injury; Reaction

  MAUDE report 8592157 ↗
• InjuryMar 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE BHA WAS DONE WITH CENTRAX BIPOLAR CUP, V40 HEAD AND ACCOLADE 2 STEM AT (B)(6) 2018 FOR FEMORAL NECK FRACTURE. AT (B)(6) 2018, INFECTION WAS OCCURRED AND THE SURGEON CLEANED THE SURGICAL FIELD, EXCHANGED THE HEAD AND CUP. THE STEM WAS NOT CHANGED. AT (B)(6) 2019, THE PATIENT WAS RECOVERED. INFECTION WAS CONFIRMED CLINICALLY, MICROORGANISM UNKNOWN. PRE-EXISTING CONDITIONS: "STOMACH CANCER"; RIGHT SIDE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8436280 ↗