Dall-Miles 6704-0-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327013306), received between May 16, 2019 and May 16, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 21, 2021Class IIOpen, Classified

   There is a potential for the outer Tyvek lid to de-bond from the sealed package.

   Z-0645-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2019Fracture; Fracture

  PATIENT CALLED STATING SHE HAD A RIGHT HIP REPLACEMENT IN (B)(6) 2008, SHE STATED SHE HAD EXPERIENCED PAIN FOR SEVERAL YEARS AND PT HASN'T HELPED MUCH. PATIENT IS SCHEDULED FOR A REVISION SURGERY IN 2 WEEKS DUE TO LOOSENING OF STEM AND ELEVATED LEVELS OF COBALT AND CHROMIUM. PATIENT ALSO WANTS TO KNOW IF HER IMPLANT WAS SUBJECT TO A RECALL. UPDATE 30-NOV-2018: PATIENT WAS REVISED (B)(6) 2018. UPDATE 11/DECEMBER/2018: REP REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED AFTER PATIENT COMPLAINT OF PAIN, AND DUE TO METAL ON METAL BEARING SURFACE. INTRAOPERATIVELY, A LARGE PSEUDO-TUMOR WAS NOTED. ADDITIONAL UPDATE 11/DECEMBER/2018: REVISION OPERATIVE REPORT SUPPLIED BY REP INDICATED THE 46MM UNIPOLAR HEAD, SLEEVE, AND 3 CABLES WERE EXPLANTED AND "MDM WITH A 46MM OUTER DIAMETER AND 28MM +8 METALLIC HEAD" WERE IMPLANTED. UPDATE 22/APRIL/2019: MEDWATCH (MW5085656) RECEIVED, PATIENT REPORTED " [...] I WAS IN EXCRUCIATING PAIN FOR YEARS AND SUFFERED NUMEROUS HEALTH PROBLEMS INCLUDING AN UNEXPLAINED HEART ATTACK ON [...] 2017".

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

  MAUDE report 8615361 ↗