Dall-Miles 6704-0-520Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327036466), received between Jul 19, 2018 and Sep 7, 2022 — classified as 4 injuries, 5 malfunctions.

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

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionApr 17, 2020Fracture; Fracture

  DURING A PRIMARY SURGERY, 2 SEPARATE DALL MILES CABLES WITH DIFFERENT LOT CODES BROKE DURING SURGERY. SURGICAL DELAY 1MIN, SURGERY COMPLETED SUCCESSFULLY. PHOTOS AND DEVICE NOT AVAILABLE. NO FURTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9973192 ↗
• MalfunctionApr 17, 2020Fracture; Fracture

  DURING A PRIMARY SURGERY, 2 SEPARATE DALL MILES CABLES WITH DIFFERENT LOT CODES BROKE DURING SURGERY. SURGICAL DELAY 1MIN, SURGERY COMPLETED SUCCESSFULLY. PHOTOS AND DEVICE NOT AVAILABLE. NO FURTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9973186 ↗
• InjuryAug 15, 2019Break; Break

  A SHORT 44 NO 1 EXETER STEM WAS REVISED DUE TO A PERIPROSTHETIC FRACTURE AT THE TIP OF THE STEM. THE SURGEON REPORTED THE STEM HAD BEEN IMPLANTED (B)(6) 2019 AND A BREACH OF THE FEMORAL CORTEX HAD OCCURRED AT THE TIME OF THE SURGERY. THIS WAS TREATED WITH DALL MILES CABLES, BUT SUBSEQUENTLY WENT ON TO FRACTURE DISTAL TO THE STEM TIP. UPDATE: ONE CABLE WAS REPORTEDLY BROKEN.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 8897149 ↗
• InjuryJul 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PAIN AND ALTR. THE HEAD, LINER AND A CABLE (WHICH HAD BEEN IMPLANTED PROPHYLACTICALLY IN THE PRIMARY PROCEDURE) WERE REVISED. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Pain; Reaction

  MAUDE report 8811338 ↗
• MalfunctionJun 11, 2019Component Missing; Component Missing

  CABLE BOX DID NOT CONTAIN CABLE. UPDATE 15/MAY/2019: SPOKE TO REP. REP WAS NOT PRESENT FOR THE EVENT. IT IS UNKNOWN IF THIS OCCURRED WITH THE PATIENT IN THE OPERATING ROOM AND/ OR UNDER ANESTHESIA. THE NATURE OF THE PROCEDURE BEING PERFORMED WAS UNKNOWN. THE REASON THE DEVICE WAS BEING IMPLANTED IS UNKNOWN. THE HOSPITAL AND SURGEON WILL NOT RELEASE ANY ADDITIONAL INFORMATION FOR THE CASE. THE REP DOES HAVE ONE PICTURE, AND WILL TRY TO CONFIRM IF THE PACKAGING IS AVAILABLE FOR RETURN, BUT HAS NO ACCESS TO ANY ADDITIONAL INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8686461 ↗
• MalfunctionJul 19, 2018Break; Fracture; Break; Fracture

  LONG GAMMA WAS TREATED FOR TROCHANTER FRACTURE. USE DALL MILES WITH BEADS FOR REDUCTION. ALTHOUGH IT WAS REDUCED WITH A REDUCTION FORCEPS, DISSECTION OF THE BONE FRAGMENT WAS A LITTLE BIG. WOUND A CABLE AND APPLIED A TENSION AGAIN WITH A TENSIONER, BUT THE DISSECTION DID NOT DISAPPEAR. AFTER ADDING MORE TENSION, THE CABLE WAS BROKEN. ADDITIONAL INFORMATION CONFIRMED; THE PRIMARY SURGERY WERE NOT STRYKER PRODUCTS, THE FRACTURE OCCURRED AND A DALL MILES CABLE WAS CHOSEN TO FIX.

  Patient problems: Bone Fracture(s)

  MAUDE report 7703737 ↗