REDAPT 71352352Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556657812), received between Sep 17, 2024 and Nov 4, 2025 — classified as 4 injuries.

1 other recall cover devices cleared under the same FDA submission (K182109, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A THR SURGERY PERFORMED ON AN UNKNOWN DATE, THE PATIENT FELL, SUSTAINED A DISLOCATION, AND WAS SUBSEQUENTLY REDUCED. THE CUP WAS FOUND TO HAVE SHIFTED VERTICALLY. THE ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2025, DURING WHICH IT WAS OBSERVED THAT THE LOCKING SCREW TABS WERE SEPARATED FROM THE CUP. ALL HARDWARE AND LOCKING TABS WERE SUCCESSFULLY REMOVED, AND THE CUP WAS EXCHANGED WITH A SLICE AUGMENT AND AN UPSIZED CUP. THE PATIENT¿S CURRENT HEALTH STATUS IS STABLE.

  Patient problems: Joint Dislocation

  MAUDE report 23461216 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT THA REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2023, THE PATIENT EXPERIENCED PAIN. A I&D PROCEDURE WAS CARRIED OUT ON THE (B)(6) 2024 AND THE PATIENT WAS CONFIRMED WITH A HIP INFECTION BY MSSA. A REVISION SURGERY WAS THEN PERFORMED ON THE (B)(6) 2024, IN WHICH ANTIBIOTIC SPACERS WERE PLACED UNTIL THE (B)(6) 2024 WHEN THE PATIENT RECEIVED NEW IMPLANTS. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Bacterial Infection; Pain

  MAUDE report 21067258 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT THA IN (B)(6) 2021 DUE TO RIGHT HIP OSTEOARTHRITIS. LATER, ON (B)(6) 2021 PATIENT SUFFERED FROM A SUPERFICIAL WOUND INFECTION THAT REQUIRED READMISSION. THERE IS NO FURTHER INFORMATION AT THIS TIME. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Post Operative Wound Infection

  MAUDE report 20241507 ↗
• InjurySep 17, 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 THE LEFT HIP ON (B)(6) 2021, DUE TO MECHANICAL LOOSENING OF INTERNAL LEFT HIP PROSTHETIC JOINT. DURING THE REVISION SURGERY, THE PRIMARY THA SYSTEM WAS EXPLANTED AND REPLACED WITH A THA ACETABULAR REDAPT SYSTEM AND A REDAPT FEMORAL SYSTEM. THE IDENTITY OF THE HIP SYSTEM IMPLANTED BEFORE THIS REVISION SURGERY IS UNKNOWN. AS REPORTED, THE PATIENT SUFFERED FROM A INFECTION OF THE PROSTHESIS. THE ISSUE WAS RESOLVED BY PERFORMING A REVISION SURGERY ON (B)(6) 2024. DURING THIS REVISION SURGERY, THE ACETABULAR COMPONENTS AND THE FEMORAL HEAD WERE EXPLANTED. THERE IS NO FURTHER INFORMATION AT THIS TIME. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 20238634 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K182109, 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.