Dall-Miles 6704-0-510Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327036442), received between Feb 5, 2018 and Jul 22, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Degraded” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2024Degraded; Degraded

  AS REPORTED: "PATIENT WAS BROUGHT IN FOR A HIP REVISION. PATIENT WAS HAVING PAIN AND HIGH COBALT LEVELS INDICATED METALLOSIS PER [SURGEON]. EXPLANTED HEAD AND LINER BUT RETAINED STEM. METAL DEBRIS AND SOFT TISSUE DAMAGE NOTED, DAMAGE TO TRUNNION OF STEM BUT DIDN'T WARRANT PULLING IMPLANT. [SURGEON] HAD TO DEBRIDE SOFT TISSUE AND REPAIR TO THE BEST OF HIS ABILITY. REPLACED HEAD AND LINER". PATIENT WAS REVISED TO A 36 +5 BIOLOX HEAD AND SLEEVE AND 36E LINER. UPDATE FROM MEDICAL REVIEW: MOVEMENT BETWEEN A DM-CABLE AND UNDERLYING SOFT TISSUES HAS GRADUALLY BUT PERSISTENTLY CONTRIBUTED TO LOCAL METALLIC DEBRIS GENERATION WITH LOCAL TISSUE METALLOSIS AND ELEVATED BLOOD COBALT LEVELS REQUIRING REVISION

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 19790429 ↗
• InjuryJul 22, 2024Degraded; Degraded

  AS REPORTED: "PATIENT WAS BROUGHT IN FOR A HIP REVISION. PATIENT WAS HAVING PAIN AND HIGH COBALT LEVELS INDICATED METALLOSIS PER [SURGEON]. EXPLANTED HEAD AND LINER BUT RETAINED STEM. METAL DEBRIS AND SOFT TISSUE DAMAGE NOTED, DAMAGE TO TRUNNION OF STEM BUT DIDN'T WARRANT PULLING IMPLANT. [SURGEON] HAD TO DEBRIDE SOFT TISSUE AND REPAIR TO THE BEST OF HIS ABILITY. REPLACED HEAD AND LINER". PATIENT WAS REVISED TO A 36 +5 BIOLOX HEAD AND SLEEVE AND 36E LINER. UPDATE FROM MEDICAL REVIEW: MOVEMENT BETWEEN A DM-CABLE AND UNDERLYING SOFT TISSUES HAS GRADUALLY BUT PERSISTENTLY CONTRIBUTED TO LOCAL METALLIC DEBRIS GENERATION WITH LOCAL TISSUE METALLOSIS AND ELEVATED BLOOD COBALT LEVELS REQUIRING REVISION.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 19790424 ↗
• InjuryJul 22, 2024Degraded; Degraded

  AS REPORTED: "PATIENT WAS BROUGHT IN FOR A HIP REVISION. PATIENT WAS HAVING PAIN AND HIGH COBALT LEVELS INDICATED METALLOSIS PER [SURGEON]. EXPLANTED HEAD AND LINER BUT RETAINED STEM. METAL DEBRIS AND SOFT TISSUE DAMAGE NOTED, DAMAGE TO TRUNNION OF STEM BUT DIDN'T WARRANT PULLING IMPLANT. [SURGEON] HAD TO DEBRIDE SOFT TISSUE AND REPAIR TO THE BEST OF HIS ABILITY. REPLACED HEAD AND LINER". PATIENT WAS REVISED TO A 36 +5 BIOLOX HEAD AND SLEEVE AND 36E LINER. UPDATE FROM MEDICAL REVIEW: MOVEMENT BETWEEN A DM-CABLE AND UNDERLYING SOFT TISSUES HAS GRADUALLY BUT PERSISTENTLY CONTRIBUTED TO LOCAL METALLIC DEBRIS GENERATION WITH LOCAL TISSUE METALLOSIS AND ELEVATED BLOOD COBALT LEVELS REQUIRING REVISION.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 19790367 ↗
• InjuryJan 18, 2024Degraded; Loss of Osseointegration; Degraded; Loss of Osseointegration

  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) 2021. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD. UPDATE: PER MEDICAL RECORDS RECEIVED: PAIN, OSTEOLYSIS, ALTR DUE TO METALLIC WEAR DEBRIS, AND BONE DEFICIENCY AROUND THE STEM WERE ALSO REPORTED. THE HEAD AND LINER WERE REVISED. THE POLYETHYLENE LINER WAS OBSERVED TO HAVE WORN IN A SYMMETRIC FASHION. THE DALL-MILES CABLE WAS REMOVED AND UNNEEDED. IT WAS LOOSE AND ABRADING THE PROXIMAL PORTION OF THE STEM SLIGHTLY. REPAIR OF THE ABDUCTOR MUSCLE TEAR WAS PERFORMED AS WELL AS A BONE GRAFT AND CEMENT TO ADDRESS THE THIN CORTICAL BONE AROUND THE STEM. THE STEM WAS WELL-FIXED AND NOT REVISED. THE TRUNNION WAS IN USABLE CONDITION WITH MILD VISIBLE BURNISHING AND CORROSION DAMAGE.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Muscle/Tendon Damage; Osteolysis; Pain

  MAUDE report 18533019 ↗
• 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. 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 8615362 ↗
• 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 8615314 ↗
• InjuryMay 15, 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: Inflammation; Injury; Pain; Reaction

  MAUDE report 8613662 ↗
• InjuryMay 1, 2019Degraded; Degraded

  AS REPORTED: "PATIENT WAS BROUGHT IN FOR A HIP REVISION. PATIENT WAS HAVING PAIN AND HIGH COBALT LEVELS INDICATED METALLOSIS PER [SURGEON]. EXPLANTED HEAD AND LINER BUT RETAINED STEM. METAL DEBRIS AND SOFT TISSUE DAMAGE NOTED, DAMAGE TO TRUNNION OF STEM BUT DIDN'T WARRANT PULLING IMPLANT. [SURGEON] HAD TO DEBRIDE SOFT TISSUE AND REPAIR TO THE BEST OF HIS ABILITY. REPLACED HEAD AND LINER". PATIENT WAS REVISED TO A 36 +5 BIOLOX HEAD AND SLEEVE AND 36E LINER. UPDATE FROM MEDICAL REVIEW: MOVEMENT BETWEEN A DM-CABLE AND UNDERLYING SOFT TISSUES HAS GRADUALLY BUT PERSISTENTLY CONTRIBUTED TO LOCAL METALLIC DEBRIS GENERATION WITH LOCAL TISSUE METALLOSIS AND ELEVATED BLOOD COBALT LEVELS REQUIRING REVISION.

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

  MAUDE report 8568436 ↗
• InjuryJul 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT REVISION SURGERY OF HER RIGHT HIP IN (B)(6) 2017. SUBSEQUENTLY SHE DISLOCATED THREE TIMES AND A SPIKA CAST WAS APPLIED. STEM CAME OUT FROM BRACE AND ANOTHER REVISION HAD TO BE DONE. UPDATED PER MEDICAL REVIEW: ¿ON (B)(6) 2017 A REVISION RIGHT TOTAL HIP ARTHROPLASTY (FEMUR ONLY) WAS PERFORMED FOR AN "UNSTABLE RIGHT THA DUE TO STEM SUBSIDENCE". THE OPERATIVE REPORT NOTES GENERAL ANESTHESIA AND USE OF THE PREVIOUS INCISION, AND DURING THIS SURGERY THE S&N REVISION STEM WAS CHANGED TO A LARGER STEM, AND UNCOMPLICATED SURGERY WAS DESCRIBED.¿ UPDATED MEDICAL RECORDS NOTED DEVICES WERE OF COMPETITOR SYSTEM, STEM AND HEAD WITH 3 STRYKER CABLES FOR THE EVENT OF SUBSIDENCE.

  Patient problems: Injury

  MAUDE report 7655382 ↗
• InjuryFeb 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  FOLLOWING A REVIEW OF THE PROVIDED IMPLANT SHEETS IT WAS IDENTIFIED THAT AN INFECTION EVENT HAD TAKEN PLACE IN 2017.

  Patient problems: Unspecified Infection

  MAUDE report 7242707 ↗