Citation 6265-5105Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613153074281), received between Oct 17, 2018 and Oct 22, 2018 — classified as 2 injuries.

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

• InjuryOct 22, 2018Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED BY THE PATIENT AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY AFTER THE IMPLANTATION HE DEVELOPED PAIN AND SWELLING WHICH WORSENS AS TIME WENT BY. DURING THE NEXT TWO YEARS BESIDES THE PAIN AND SWELLING THE LEG STARTED TO THUMP WHEN HE WALKED AND SOMETIMES THE HIP WOULD LOCK UP AND COULD NOT MOVE. IT IS FURTHER ALLEGED THAT THE PATIENT WAS REVISED ON (B)(6) 2017 AND DURING THE PROCEDURE THE SURGEON FOUND THAT THE BALL HAD DISINTEGRATED IN THE LEG AND FOUR HOURS WERE SPENT PICKING OUT SHARDS AND SPLINTERS THAT HAD EMBEDDED IN HIS LEG. UPDATE PER MEDICAL REVIEW: ¿ON (B)(6) 2017 HE HAD A LEFT HIP ASPIRATION UNDER LOCAL ANESTHESIA AND FLUOROSCOPIC CONTROL. TOE FLUID WAS SENT FOR GRAM STAIN, CULTURE AND CELL COUNT. LAB REPORT OF RESULTS OF (B)(6) 2017 LEFT HIP ASPIRATE RESULTS: "NO ORGANISMS SEEN" ON GRAM STAIN AND "NO GROWTH AT 3 DAYS" ON CULTURE. CELL COUNT FROM ASPIRATE IS NOT DIAGNOSTIC OF INFECTION.¿ ¿ON (B)(6) 2017 A REVISION LEFT TOTAL HIP ARTHROPLASTY (BOTH COMPONENTS) FOR A PRE­ AND POST-OPERATIVE DIAGNOSIS OF "LEFT HIP PAIN STATUS-POST THA, DISLOCATED LEFT HIP, LOOSENING OF HARDWARE". A BRIEF OPERATIVE REPORT DESCRIBES SPINAL ANESTHESIA AND A LATERAL APPROACH. THE

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Injury; Joint Dislocation; Pain; Swelling

  MAUDE report 7992444 ↗
• InjuryOct 17, 2018Corroded; Insufficient Device Problem Information; Corroded; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS LEFT HIP ON OR ABOUT (B)(6) 2011 AND WAS REVISED ON (B)(6) 2018. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE AND EXCESSIVE LEVELS OF COBALT AND CHROMIUM IN HIS BLOOD.

  Patient problems: Foreign Body Reaction; Inflammation; Injury; Metal Related Pathology; Reaction

  MAUDE report 7975874 ↗