Citation 6265-5114Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613153074373), received between Sep 5, 2018 and Aug 31, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2026Degraded

  It was reported that the patient's Right hip was revised after patient complaint of pain. Intra-operatively, the following was reported: There was a moderate amount of black tissue removed. OR staff remarked that the liner appeared more yellow than expected. The stem, though well-fixed, had corrosion on the trunnion. The trunnion was cleaned off, and the well-fixed stem and shell remained in situ. Rep confirmed that no further information will be released by the hospital or surgeon.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 50516764 ↗
• InjuryFeb 28, 2023Fracture; Fracture

  IT WAS REPORTED THE PATIENT'S RIGHT HIP WAS REVISED DUE TO THE NECK OF THE STEM (DISTAL TO THE HEAD) BREAKING. THE STEM, HEAD, AND ADM/ MDM POLY INSERT WERE REVISED TO AN ADM/ MDM POLY INSERT AND COMPETITOR FEMORAL IMPLANTS. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS (INCLUDING DAMAGE) AGAINST THE REVISED HEAD OR POLY. REP ALSO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 16450558 ↗
• InjuryFeb 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE PATIENT 'S ATTORNEY THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2012 AND WAS IMPLANTED WITH A 36 MM +5 LFIT ANATOMIC V40 FEMORAL HEAD AND AN CITATION TMZF HIP STEM. THE PATIENT WAS REVISED ON (B)(6) 2021 DUE TO HEAD DISASSOCIATION.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 16282763 ↗
• InjuryApr 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO HEAD DISSOCIATION AND TRUNNION WEAR. THE STEM, HEAD AND LINER WERE REVISED. NO ALLEGATIONS AGAINST THE LINER WERE REPORTED TO THE REP. PATIENT WAS REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, CERAMIC HEAD, AND ADM/ MDM LINER CONSTRUCT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 14114918 ↗
• MalfunctionDec 10, 2018Difficult to Insert; Difficult to Insert

  IMPLANT BROACH WAS FLUSH TO THE NECK RESECTION, AND SAT PROUD BY AT LEAST 4MM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8148708 ↗
• InjuryNov 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PER MEDICAL REVIEW: "ON (B)(6) 2014 AN MRI OF THE RIGHT HIP REPORT NOTES, " ... PERSISTENT DISTENTION OF PSEUDOCAPSULE BY HYPERTROPHIC ... SYNOVIAL EXPANSION IN KEEPING WITH THE FEATURES OF AL TR ... INTERVAL DEFICIENCY OF POSTEROLATERAL AND LATERAL CAPSULE, AS WELL AS DETACHMENT OF GLUTEUS MEDIUS INSERTION ..EFFECTS OF POST-SURGICAL CHANGES ... RESIDUAL CHANGES GREATER TROCHANTER BURSA ... WITHOUT ... COMPONENT LOOSENING."

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 8117725 ↗
• InjurySep 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT "PATIENT HAS BEEN EXPERIENCING PAIN PRETTY MUCH SINCE THE BEGINNING OF HER SURGERY 4 YEARS AGO. DR.'S ARE SAYING THAT THE IMPLANT IS IN PLACE. CHIROPRACTOR BELIEVES THAT THE IMPLANT IS OVERSIZED, CAN SEE IT PROTRUDING THROUGH HER SKIN AND CAN BE AFFECTING THE MUSCLE. SHE HAS A TRIDENT ACETABULAR SHELL." UPDATE AS PER LEGAL CORRESPONDENCE: IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY AFTER THA, THE PATIENT BEGAN EXPERIENCING DISCOMFORT IN THE AREA OF THE DEVICE. IT IS FURTHER ALLEGED THAT "WORKUP REVEALED THE PRESENCE OF MARKEDLY INCREASED LEVELS OF METAL IONS IN THE PATIENT'S BLOOD" AND "THE POTENTIAL EXISTENCE OF PSEUDOTUMOR WITH EVIDENCE OF AN ADVERSE LOCAL TISSUE REACTION". PER THE LAWSUIT, IT WAS REPORTED THAT THE REVISION SURGERY TOOK PLACE AT THE HOSPITAL FOR SPECIAL SURGERY IN (B)(6) CITY ON (B)(6) 2013.

  Patient problems: Discomfort; Edema; Inflammation; Injury; Pain; Reaction

  MAUDE report 7845802 ↗