REDAPT 71354486Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556580806), received between Sep 16, 2024 and Sep 18, 2024 — classified as 2 injuries.

1 other recall cover devices cleared under the same FDA submission (K151902, K211176); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT REVISION SURGERY IN (B)(6) 2022 DUE TO ACUTE PELVIC DISCONTINUITY AND ACETABULAR FRACTURE. DURING THE REVISION SURGERY A SMITH & NEPHEW SYSTEM WAS IMPLANTED. THE IDENTITY OF THE PRIMARY HIP SYSTEM IS UNKNOWN. LATER, ON (B)(6) 2022 PATIENT SUFFERED FROM AN UNSPECIFIED FRACTURE OF SHAFT OF LEFT FEMUR THAT REQUIRED AN ADDITIONAL SURGICAL INTERVENTION. THERE IS NO FURTHER INFORMATION AT THIS TIME. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 20246928 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF HER RIGHT THA SYSTEM (UNKNOWN PRODUCT) ON (B)(6) 2020 DUE TO A PERIPROSTHETIC RIGHT FEMUR FRACTURE. DURING THE REVISION SURGERY, THE WHOLE PRIMARY THA SYSTEM WAS EXPLANTED AND REPLACED WITH A REDAPT MODULAR SHELL AND A REDAPT FEMORAL SYSTEM, ALONG WITH A CABLE/SLEEVE ORTHOPEDIC 2MM DALL-MILES HIP VITALLIUM SET FROM A COMPETITOR. AS REPORTED, THE PATIENT SUFFERED FROM A POSTOPERATIVE PERIPROSTHETIC RIGHT FEMUR FRACTURE AROUND THE PROSTHESIS ON (B)(6) 2020. THE PATIENT UNDERWENT A REVISION SURGERY WITHIN THE SAME MONTH TO ADDRESS THE ISSUE. DURING THIS SECOND SURGERY, THE INTERNAL FIXATION SYSTEM OF RIGHT FEMUR WAS REVISED. THERE IS NO FURTHER INFORMATION AT THIS TIME. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Hip Fracture

  MAUDE report 20233283 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151902, K211176. 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.