Anato 4845-7-114Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252631156), received between Mar 8, 2019 and Oct 15, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; 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 HER RIGHT HIP ON OR ABOUT (B)(6) 2016 AND WAS REVISED ON (B)(6) 2017. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICES AT ISSUE AND DEVICE RECALL.

  Patient problems: Injury; Metal Related Pathology

  MAUDE report 9192771 ↗
• InjuryJul 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE REVISED IMPLANTS OF THE RIGHT HIP. IT WAS REPORTED THAT THE PATIENT SUFFERED BILATERAL FEMORAL FRACTURES 6 DAYS AFTER HAVING A BILATERAL HIP REPLACEMENT. THE ANATO STEMS AND BIOLOX HEADS WERE REVISED TO RESTORATION MODULAR STEM CONSTRUCTS AND BIOLOX HEADS.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 8758224 ↗
• InjuryMar 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  DOCTOR REPORTS PATIENT STATUS POST RIGHT TOTAL HIP DONE ON (B)(6) 2019 NOW HAS A PERIPROSTHETIC FRACTURE AROUND THE RIGHT FEMORAL COMPONENT AND HE WOULD LIKE TO REVISE TO A RESTORATION MODULAR HIP. THE SURGERY WAS PERFORMED PER RESTORATION MODULAR SURGICAL TECHNIQUE. 3 CABLES WERE APPLIED. SURGERY WAS PERFORMED WITHOUT INCIDENT. UPDATE 14/FEBRUARY/2019: AS REPORTED IN HOW WAS ISSUE NOTICED "X-RAY PATIENT COMPLAINT OF PAIN UNABLE TO AMBULATE".

  Patient problems: Hip Fracture; Injury; Pain

  MAUDE report 8403515 ↗