V40 Head 6260-9-026Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327012989), received between Jan 12, 2018 and Feb 22, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 22, 2019Unstable; Unstable

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED FROM A HEMI TO A TOTAL HIP 4 DAYS POST-OP DUE TO INSTABILITY. POSSIBLE CAUSE OR CONTRIBUTOR TO INSTABILITY WAS NOT REPORTED TO THE REP. A 47X26 BIPOLAR COMPONENT AND 26 -3 METAL HEAD WERE REVISED TO A TOTAL HIP CONSTRUCT WITH A 54MM SHELL AND SCREW, ADM/MDM LINER CONSTRUCT, AND BIOLOX CERAMIC HEAD.

  Patient problems: Injury

  MAUDE report 8361412 ↗
• MalfunctionOct 18, 2018Difficult to Insert; Mechanical Problem; Difficult to Insert; Mechanical Problem

  PRIMARY PROCEDURE, HIP. IT WAS REPORTED THAT UPON IMPACTION, THE FEMORAL HEAD WAS TOO LARGE FOR THE TRUNNION AND WOULD NOT STAY ON. A FEMORAL HEAD OF THE SAME CATALOG NUMBER BUT DIFFERENT LOT WAS USED AND PERFORMED AS EXPECTED, ADDING AN APPROXIMATE 2 MINUTE SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7981005 ↗
• InjuryJan 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED. EXPLANTED DEVICES ARE UHR UNIVERSAL HEAD, CONE BODY, AND LFIT V40 FEMORAL HEAD (BOTH IMPLANTED (B)(6) 2017). INITIAL SURGERY (B)(6)2017 WAS PERFORMED DUE TO A FAILED COMPETITOR IM HIP NAIL. 1ST AND 2ND REVISION WAS DUE TO NON-COMPLIANT PATIENT VS HIP INSTABILITY.

  Patient problems: Injury

  MAUDE report 7186662 ↗