Accord 71340020Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010485724), received between Sep 10, 2018 and Nov 12, 2021 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K031162, K211176, K223762, K233949); they may or may not involve this specific model.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 2021Break; Break

  IT WAS REPORTED THAT DURING A REVISION SURGERY FOLLOWING A THR (THE MANUFACTURER IS UNKNOWN SINCE THE DEVICES ARE IMPLANTED 10 YEARS AGO), A BINDING CABLE OF A ACCORD 2.0MM COBALT CHROME CABLE SUDDENLY BROKE DURING THE OPERATION, WHICH FRIGHTENED THE SURGEON AND QUESTIONED THE PRODUCT QUALITY. THERE WAS A DELAY OF 30 MINUTES OR LESS AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12806659 ↗
• MalfunctionJul 22, 2019Break; Break

  IT WAS REPORTED THAT THE SCREW WHICH IS ASSEMBLED WITH THE CRAMP BREAK INTO THE FEMORAL BONE. THE DOCTOR CONCERNS THE SCREW MAKE THE OSTEO BONE DAMAGE, SUCH AS FRACTURE. PROCEDURE DELAYED LESS THAN 30 MINUTES. BACKUP DEVICE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8814267 ↗
• InjurySep 27, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT VISITED THE HOSPITAL FOR DIAGNOSIS AND TREATMENT BECAUSE OF PAIN AFTER GOT SPRAIN OF RIGHT THIGH BECAUSE OF BODY INSTABILITY. EXTERNAL FIXATION WITH SUPPORT PLATE WAS PERFORMED, AND LAPPACONITINE WAS INJECTED FOR ANALGESIA IN EMERGENCY DEPARTMENT, AFTER WHICH THE PATIENT WAS ADMITTED WITH DIAGNOSIS OF INVALID INTERNAL FIXATION AFTER SURGERY FOR RIGHT FEMORAL PROSTHESIS PERIPHERAL BONE FRACTURE IN 2017.

  Patient problems: Pain

  MAUDE report 7914053 ↗
• InjurySep 27, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT VISITED THE HOSPITAL FOR DIAGNOSIS AND TREATMENT BECAUSE OF PAIN AFTER GOT SPRAIN OF RIGHT THIGH BECAUSE OF BODY INSTABILITY. EXTERNAL FIXATION WITH SUPPORT PLATE WAS PERFORMED, AND LANNACONITINE WAS INJECTED FOR ANALGESIA IN EMERGENCY DEPARTMENT, AFTER WHICH THE PATIENT WAS ADMITTED WITH DIAGNOSIS OF INVALID INTERNAL FIXATION AFTER SURGERY FOR RIGHT FEMORAL PROSTHESIS PERIPHERAL BONE FRACTURE IN 2017.

  Patient problems: Injury; Pain

  MAUDE report 7914052 ↗
• InjurySep 10, 2018Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO THE CABLES BROKE INSIDE THE PATIENT.

  Patient problems: Injury

  MAUDE report 7862770 ↗
• InjurySep 10, 2018Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO THE CABLES BROKE INSIDE THE PATIENT.

  Patient problems: Injury

  MAUDE report 7862758 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031162, K211176, K223762, K233949. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.