Dall-MilesRecalls & reported problems across all models

We found 12 models of Dall-Miles by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 36 adverse event reports in the FDA's MAUDE database, received between Feb 5, 2018 and Jul 31, 2026 — classified as 26 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (14 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Dall-Miles recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 21, 2021Open, 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 Dall-Miles problems

Dall-Miles models

12 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Dall-Miles 6704-0-110

  CERCLAGE, FIXATION
  1 recall1 report
• Dall-Miles 6704-0-510

  CERCLAGE, FIXATION
  10 reports
• Dall-Miles 6704-0-520

  CERCLAGE, FIXATION
  9 reports
• Dall-Miles 3704-0-050

  CERCLAGE, FIXATION
  4 reports
• Dall-Miles 6704-8-240

  CERCLAGE, FIXATION
  3 reports
• Dall-Miles 3704-0-510

  CERCLAGE, FIXATION
  2 reports
• Dall-Miles 6704-0-420

  CERCLAGE, FIXATION
  2 reports
• Dall-Miles 6704-3-081

  CERCLAGE, FIXATION
  1 report
• Dall-Miles 3704-2-082

  FIXATION ACCESSORY
  1 report
• Dall-Miles 3704-0-040

  CERCLAGE, FIXATION
  1 report
• Dall-Miles 3704-3-110

  PLATE, FIXATION, BONE
  1 report
• Dall-Miles 3704-3-120

  PLATE, FIXATION, BONE
  1 report

Recent Dall-Miles adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2026Fracture

  The following information was provided: Left hip. Patient revised as one of the cable snapped. Surgeon removed all cables and cable plate. Surgeon attempted to re-implant a new, longer cable plate but changed his mind during the case. No other information available due to hospital policy.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 50101874 ↗
• InjuryOct 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO NEW INFORMATION.

  Patient problems: Fistula; Unspecified Infection

  MAUDE report 23208218 ↗
• InjuryJan 29, 2025Fracture; Fracture

  REVISION PROCEDURE OF PROXIMAL FEMUR GMRS. MULTIPLE PREVIOUS REVISIONS; CABLES IMPLANTED DURING PROCEDURE (B)(6) 2023. NO DETAILS AVAILABLE OF PROCEDURES PRIOR TO THIS DATE. DALL MILES CABLE HAD SNAPPED AND FRAYED IN THE PATIENT. CABLES AND CABLE GRIP REMOVED AND FRAYED METAL REMOVED UNDER X RAY GUIDANCE. NO NEW IMPLANTS WERE PUT IN. ALL OF THE ITEMS ARE STILL IN PATIENT EXCEPT FOR THE CABLES AND CABLE GRIP WHICH WERE REMOVED DURING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21263920 ↗
• InjuryJan 29, 2025Fracture; Fracture

  REVISION PROCEDURE OF PROXIMAL FEMUR GMRS. MULTIPLE PREVIOUS REVISIONS: CABLES IMPLANTED DURING PROCEDURE (B)(6) 2023. NO DETAILS AVAILABLE OF PROCEDURES PRIOR TO THIS DATE. DALL MILES CABLE HAD SNAPPED AND FRAYED IN THE PATIENT. CABLES AND CABLE GRIP REMOVED AND FRAYED METAL REMOVED UNDER X RAY GUIDANCE. NO NEW IMPLANTS WERE PUT IN. ALL OF THE ITEMS ARE STILL IN PATIENT EXCEPT FOR THE CABLES AND CABLE GRIP WHICH WERE REMOVED DURING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21263918 ↗
• 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 ↗
• InjurySep 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  I&D OF AN INFECTED HIP. HE CHANGED A DALL-MILES CABLE (NOTE: 4 ORIGINALLY IMPLANTED, UNKNOWN WHICH WAS REMOVED), LINER AND HEAD. NO ALLEGATIONS AGAINST THE IMPLANTS MADE.

  Patient problems: Unspecified Infection

  MAUDE report 15370274 ↗
• InjuryFeb 15, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PATIENT STATED SHE HAD A LEFT THA ON (B)(6) 2016. TWO HOURS AFTER HER SURGERY THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM AND WAS TOLD THE PIECE FAILED AND WAS REVISED. PATIENT STATED SHE WAS EXPERIENCING PAIN AND HAVE SEEN HER SURGEON BUT WAS TOLD THAT EVERYTHING WAS FINE. THE PATIENT SOUGHT A SECOND OPINION ON (B)(6) 2018 AND WAS REVISED DUE TO HER X-RAY FINDINGS. PATIENT CONTINUED TO EXPERIENCE PAIN AND WAS REVISED ON (B)(6)2019. PATIENT IS STILL EXPERIENCING EXCRUCIATING PAIN. PATIENT HAS BEEN IN AND OUT OF THE HOSPITAL FOR THE PAST 5 YEARS AND IS SEEKING COMPENSATION FOR ALL HER SUFFERING. THIS PI IS FOR REVISION1. UPDATE ON 21-JAN-2022 BASED ON MED REVIEW: AN OPERATION NOTE ON (B)(6) 2018. THE POSTOPERATIVE DIAGNOSIS WAS "PAINFUL HARDWARE LEFT HIP, REMOVAL OF HARDWARE LEFT HIP, WE ARE REMOVING A CABLE OFF THE FEMUR". NO SIGNS OF INFECTION WERE NOTED A NORMAL AMOUNT OF JOINT FLUID WAS SEEN WITH NO SIGNS OF PURULENCE. FROZEN SECTION CAME BACK NOT CONSISTENT WITH INFECTION. THE CABLE WAS LOOSE AND REMOVED. A REPAIR OF THE ABDUCTOR MECHANISM WAS CARRIED OUT.

  Patient problems: Pain

  MAUDE report 13539225 ↗
• InjuryOct 4, 2021Fracture; Fracture

  SURGEON NOTIFIED ON A CASE THAT POSSIBLY NEEDED A REVISION SURGERY. THE SURGERY WAS DONE A FEW YEARS BACK USING STRYKER IMPLANTS. THE REASON ON THE REVISION SURGERY NEEDED POSSIBLY DUE TO ASEPTIC LOOSENING. PER INFORMATION REQUESTED RESPONSE: "THE CABLE SLEEVE 3704-0-510 , LOT 46496804 WAS BROKEN PRIOR TO SURGERY. DOCTORS SUSPECTED THE CABLE FAILURE."

  Patient problems: Inadequate Osseointegration

  MAUDE report 12569398 ↗
• InjuryMay 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE REMOVAL OF CABLES AND A PLATE ON (B)(6) 2015. IN PROVIDING INFORMATION FOR A REVISION OF THE PATIENT'S LEFT HIP ON (B)(6) 2021, AN OPERATIVE REPORT FOR 16/NOVEMBER/2015 WAS PROVIDED WHICH NOTES: "...UNDERWENT REVISION OF HIS...HIP REPLACEMENT IN (B)(6) 2015. HE HAS DEVELOPED SIGNIFICANT PAIN WHICH SEEMS TO BE ASSOCIATED WITH A TROCHANTERIC PLATE AND CABLES IMPLANTED TO TREAT AN INTRAOPERATIVE PROXIMAL FEMUR FRACTURE...THE FRACTURE DID NOT DISPLACE AND APPEARS TO HAVE HEALED..." ALL CABLES AND A PLATE WERE REMOVED. SPOKE TO THE REP WHO WAS PRESENT FOR THE (B)(6) 2015 REVISION. THE REP WAS NOT INFORMED OF AN INTRA-OPERATIVE FRACTURE AND WASN'T AWARE IF THE ADDITIONAL HARDWARE WAS BEING PLACED PROPHYLACTICALLY. FURTHERMORE, THE REP CONFIRMED HE WAS NOT PRESENT FOR THE PROCEDURE TO REMOVE THE PLATE AND CABLES, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 11770425 ↗
• MalfunctionMar 1, 2021Fracture; Fracture

  WHEN TIGHTENING D/M CABLE WITH SINGLE TENSIONER, CABLE WAS BROKEN INSIDE THE TENSIONER. SURGEON TIGHTENED AS USUAL.

  Patient problems: Insufficient Information

  MAUDE report 11396282 ↗
• InjuryNov 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE FIRST STAGE REVISION DUE TO INFECTION. AS REPORTED IN MEDWATCH 2302300000-2020-8005: PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY [MANUFACTURER NOT REPORTED] AND WAS DISCHARGED HOME WITHOUT COMPLICATIONS. THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT WITH A FRACTURED LEFT FEMUR AROUND HER PREVIOUS THA. SHE WAS TAKEN TO THE OR FOR REVISION OF HER LEFT FEMORAL COMPONENT WITH ORIF OF PROXIMAL FEMUR. DURING THE SURGERY, A CABLE WOULD NOT THREAD THROUGH SINGLE-SIDED TENSIONER SO THE STAFF REMOVED IT FROM SERVICE AND USED THE SECOND ONE IN THE TRAY. THAT TENSIONER WOULD ALLOW FOR A CABLE TO PASS AND SURGERY WAS COMPLETED. TWO DAYS LATER, THE CENTRAL STERILE SUPPLY MANAGER WAS EVALUATING THE "BROKEN" TENSIONER ONLY TO FIND IT WAS NOT BROKEN AT ALL BUT WAS FULL OF DEBRIS FROM PREVIOUS PATIENTS. HE THEN DISASSEMBLED THE "USED" TENSIONER TO FIND IT WAS FULL OF DEBRIS AS WELL. WE SENT OFF FOR LOANER REPLACEMENT FROM THE COMPANY AND THOSE RECEIVED, UNDER VIDEO INSPECTION, WERE FOUND TO BE CAKED WITH DEBRIS TOO. THESE DEVICES ARE DIFFICULT TO CLEAN AND VISUALLY CONFIRM CLEAN BECAUSE THEY DO NOT COME APART CLOSE TO THE DIFFICULT AREAS TO CLEAN. THE PATIENT HAS NOW DEVELOPED A

  Patient problems: Unspecified Infection

  MAUDE report 10855921 ↗
• MalfunctionAug 25, 2020Break; Break

  PRIMARY PROCEDURE, COMPETITOR HIP. IT WAS REPORTED THAT WHEN TRYING TO USE A DALL-MILES BEADED CABLE SET TO ADDRESS AN INTRA-OPERATIVE FEMORAL FRACTURE, THE CABLE BROKE. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO DELAY. REP WAS NOT PRESENT FOR THE PROCEDURE AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10451616 ↗

Other Howmedica Osteonics Corp. products

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