Accord 71340008Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010525291), received between Aug 19, 2021 and Mar 23, 2026 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN RSA HAD BEEN PERFORMED ON AN UNKNOWN DATE, PATIENT EXPERIENCED INFECTION. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2026, DURING WHICH, THE INFECTED DELTA XTEND SHOULDER IMPLANT FROM THE RIGHT SHOULDER WAS EXPLANTED. DURING PROCEDURE, THEY NOTICED PURULENT DISCHARGE WAS OBSERVED WITHIN THE HUMERAL CANAL. THE WOUND A HUMERAL CANAL WERE IRRIGATED, AND A CEMENT SPACER WITH VANCOMYCIN WAS IMPLANTED. THE ORIGINAL DELTA XTEND IMPLANT HAD BEEN PLACED DUE TO FAILURE OF A PREVIOUS ORIF (OPEN REDUCTION AND INTERNAL FIXATION) WITH PLATES AND SCREWS INCLUDING AN ACC 2.0MM SS CABLE W/CLAMP. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 24662084 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT THA RE-REVISION PERFORMED ON (B)(6) 2020 DUE TO INFECTION AND INTERTROCHANTERIC FRACTURE NONUNION, THE PATIENT REQUIRED AN ADDITIONAL REVISION ON (B)(6) 2021 DUE TO CHRONIC UNSPECIFIED INFECTION. ALL COMPONENTS WERE EXPLANTED DURING THIS PROCEDURE. THE PATIENT UNDERWENT A GIRDLESTONE PROCEDURE AS THE BONE LOSS WAS TOO SIGNIFICANT TO CONSIDER ANY ARTHROPLASTY IN THE FUTURE.

  Patient problems: Unspecified Infection

  MAUDE report 19135151 ↗
• InjuryApr 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A LEFT THA WITH ORIF PERFORMED ON (B)(6) 2019 DUE TO A SUSTAINED VANCOUVER B2 PERIPROSTHETIC INTERTROCHANTERIC FEMORAL FRACTURE AFTER A FALL, AN X-RAY FILM TAKEN ON (B)(6) 2020 AT 2 MONTHS FOLLOW UP INDICATED THE CABLE-PLATE WAS "BROKEN" WITHOUT MIGRATION OF THE TROCHANTER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 19134912 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT THA WITH ORIF - PLATE OSTEOSYNTHESIS PERFORMED ON (B)(6) 2019 DUE TO A SUSTAINED VANCOUVER B2 PERIPROSTHETIC INTERTROCHANTERIC FEMORAL FRACTURE, THE PATIENT WAS ADMITTED IN THE EMERGENCY DEPARTMENT DUE TO CELLULITIS ON (B)(6) 2019. THE PATIENT PRESENTED REDNESS AROUND THE INCISIONAL SITE AND MILD PAIN. THE PATIENT WAS PLACED ON IV ANTIBIOTICS DURING 2 DAYS AND WAS LATER DISCHARGED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Cellulitis

  MAUDE report 19134717 ↗
• MalfunctionFeb 23, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, A ACC 2.0MM SS CABLE W/CLAMP SNAPPED WHEN INSTALLING. ALL PIECES RECOVERED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13588765 ↗
• MalfunctionFeb 23, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, A ACC 2.0MM SS CABLE W/CLAMP SNAPPED WHEN INSTALLING. ALL PIECES RECOVERED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13588662 ↗
• MalfunctionAug 19, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A THR SURGERY, THREE (3) ACCORD 2.0MM STAINLESS STEEL CABLE WITH CLAMP WERE ¿FRAYING¿ BEFORE FULL TENSION WAS APPLIED. SURGERY WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12342967 ↗
• MalfunctionAug 19, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A THR SURGERY, THREE (3) ACCORD 2.0MM STAINLESS STEEL CABLE WITH CLAMP WERE ¿FRAYING¿ BEFORE FULL TENSION WAS APPLIED. SURGERY WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12342899 ↗
• MalfunctionAug 19, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A THR SURGERY, THREE (3) ACCORD 2.0MM STAINLESS STEEL CABLE WITH CLAMP WERE "FRAYING" BEFORE FULL TENSION WAS APPLIED. SURGERY WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12342860 ↗

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.