V40 Head 6260-5-128Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327012866), received between Jan 24, 2017 and Aug 31, 2022 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Unstable” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2022Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  AS REPORTED: "TOTAL HIP ARTHROPLASTY REVISION - LEFT. DIAGNOSIS: UNSTABLE HEMI-ARTHROPLASTY. NO FURTHER INFORMATION AVAILABLE PER HOSPITAL." A BIPOLAR COMPONENT AD FEMORAL HEAD WERE REVISED TO A TOTAL HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 15325747 ↗
• InjuryFeb 17, 2022Degraded; Degraded

  THE FOLLOWING WAS REPORTED: COULD BE ARMD(ADVERSE REACTION TO METALLIC DEBRIS) DUE TO TRUNNIONOSIS. REVISION.

  Patient problems: Foreign Body Reaction; Insufficient Information

  MAUDE report 13552670 ↗
• InjuryNov 7, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO ECCENTRIC WEAR OF THE POLY LINER AND INSTABILITY. A HEAD AND LINER EXCHANGE WAS PERFORMED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 12757731 ↗
• MalfunctionJul 30, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  DURING THE SURGERY THE DOCTOR NOTICED THAT TWO ITEMS WERE DEFECTIVE. ADDITIONAL INFORMATION: DURING THE SURGERY, THE OPERATOR STATED THAT THE HEAD THAT WAS SLAMMED IN THE HEAD OF UH1 WEAKLY MOVES AND WILL CAUSE DISLOCATION IN THE JOINT, HE DECIDED TO CHANGE THE HEAD AND HEAD OF UH1.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8842168 ↗
• InjuryJan 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A REPRESENTATIVE FROM THE CLINIC REPORTED THE FOLLOWING EVENT : "INSTALLATION OF AN ABG IL HIP PROSTHESIS: ALLERGY TO METALS".

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 8245227 ↗
• MalfunctionJan 24, 2017Loose or Intermittent Connection; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WHEN SURGEON WAS PERFORMING THE HIP-JOINT REPLACEMENT SURGERY, HE FOUND THAT AFTER HE CONNECTED THE ACCOLADE HFX HANDLE TO 28MM STD V40 TAPER VIT HEAD, THEY WERE LOOSENING AND COULD NOT BE FASTENED. THE SURGERY PROCESS HAS BEEN AFFECTED, AFTER COORDINATED, THE SURGEON REPLACED WITH A TAPER VIT HEAD WHICH HAS THE SAME CONE ANGEL, AND FINISHED THE SURGERY. THE SURGEON REPLACED WITH A TAPER VIT HEAD WITH A LARGER DIAMETER AND THE SAME CON ANGEL, THE SUBSTITUTE PRODUCT ITEM: 6260-5-228,28MM+4MM, AFTERWARDS THE SURGERY WAS FINISHED.

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

  MAUDE report 6272897 ↗