Citation 6265-5104Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613153074274), received between Sep 17, 2018 and Jun 5, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 16, 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.

• InjuryJun 5, 2023Degraded; Degraded

  REP RECEIVED A TEXT MESSAGE FROM A SURGEON WITH A PICTURE OF AN EXPLANTED CITATION STEM. SURGEON IS ASKING IF THE DEVICE WAS PART OF A RECALL. PER RESPONSE: "¿THE REASON FOR REVISION IS A TITANIUM ADVERSE LOCAL TISSUE REACTION. IT WAS A CERAMIC HEAD ON A POLYETHYLENE LINER, SHE HAD MULTIPLE HEAD/LINER AND CUP REVISIONS SINCE THE ORIGINAL SURGERY, THE STEM WAS THE ONLY ORIGINAL COMPONENT.¿ "NO OTHER IMPLANT INFORMATION WAS PROVIDED PATIENT HAD PREVIOUS SURGERIES PERFORMED AT DIFFERENT HOSPITAL."

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 17064126 ↗
• InjuryAug 12, 2020Device Dislodged or Dislocated; Insufficient Device Problem Information; Device Dislodged or Dislocated; Insufficient Device Problem Information

  THIS PI IS FOR REVISION OF THE PRIMARY. IT WAS REPORTED BY THE PATIENT, THAT HE RECEIVED A NOTICE FROM (B)(6) HOSPITAL REGARDING HIS LEFT HIP BEING DEFECTIVE. PATIENT WENT IN AND WAS GIVEN AN X-RAY WHICH WAS REVIEWED AND WAS TOLD THAT IT LOOKED FINE. AFTER, THE PATIENT WENT IN FOR BLOOD WORK AND HIS BLOOD WORK SHOWED HIGH LEVELS OF COBALT. TWO YEARS LATER THE PATIENT FELT A CRAMP AND WAS UNABLE TO MOVE WHILE EATING DINNER WITH A FRIEND. THE PATIENT WENT TO THE HOSPITAL WHERE THEY TOOK AN X-RAY AND WAS TOLD HE NEEDED TO BE REVISED AS HIS IMPLANT WAS BROKEN. PATIENT FELT DECENT THE FIRST 8 WEEKS AFTER HIS REVISION BUT AFTER STARTED EXPERIENCING FEVERS AND INFECTIONS, PATIENT WAS GIVEN ANTIBIOTICS. PATIENT STATED HE DOESN'T FEEL UP TO PAR, HE FEELS TIRED. HE STATES THAT HIS INNER MUSCLES ARE NOT RECUPERATING AS HE WOULD LIKE THEM TO.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 10395745 ↗
• InjuryDec 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PERIPROSTHETIC FRACTURE AROUND LEFT HIP IMPLANT. PATIENT'S STEM AND CERAMIC HEAD WERE REVISED (B)(6) 2019.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 9495188 ↗
• InjurySep 18, 2019Degraded; Insufficient Device Problem Information; Degraded; 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) 2010. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. PATIENT HAS NOT YET SCHEDULED A SURGERY FOR EXPLANTATION OF THE FEMORAL HEAD AT ISSUE.

  Patient problems: Injury; Metal Related Pathology; Pain; Reaction

  MAUDE report 9081723 ↗
• InjuryNov 15, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT PRESENTED TO DR. ON JULY 17, AND REVISED THE HIP STEM, HEAD AND LINER ON JULY 19. UPDATE: PER OPERATIVE REPORT, "LEFT HIP FAILED TOTAL HIP ARTHROPLASTY...HE WAS GETTING OUT OF A CHAIR WHEN HE FELT A SUDDEN CHANGE HAD A SIGNIFICANT PAIN...WAS NOTED TO HAVE DISSOCIATION OF THE FEMORAL HEAD AND THE STEM...THE ABDUCTORS WERE IN GOOD SHAPE. THERE WAS NO TRUE PSEUDOTUMOR OUTSIDE OF THE JOINT...THERE WAS A GUSH OF FLUID WITH THE TYPICAL BROWNISH DARK COLOR CONSISTENT WITH SOME METAL REACTION. THERE WAS SOME SURROUNDING ADVERSE LOCAL TISSUE REACTION AMONG THE CAPSULE AND EXTENDING ANTERIORLY...THE HEAD WAS OBVIOUSLY OFF THE STEM, IT WAS VERY EVIDENT THAT THE TRUNNION HAD SIGNIFICANT DAMAGE TO IT."

  Patient problems: Injury

  MAUDE report 8073663 ↗
• InjurySep 17, 2018Degraded; Insufficient Device Problem Information; Degraded; 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) 2010. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION OF THE DEVICE AT ISSUE, EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. PATIENT HAS NOT YET SCHEDULED A SURGERY FOR EXPLANTATION OF THE FEMORAL HEAD.

  Patient problems: Inflammation; Metal Related Pathology; Reaction; Unspecified Infection

  MAUDE report 7880763 ↗