REDAPT 71352360Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556657867), received between Apr 29, 2021 and Sep 17, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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

• 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 RIGHT HIP ON (B)(6) 2022, DUE TO AN UNSPECIFIED FAILURE OF THE PREVIOUS THA SYSTEM. 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 INFECTION AND INFLAMMATORY REACTION DUE TO INTERNAL RIGHT HIP PROSTHESIS. THE PATIENT UNDERWENT A 2 STAGE REVISION SURGERY: ONE IN (B)(4) 2022 AND ANOTHER ONE IN (B)(6) 2022. DURING THESE REVISION SURGERIES, THE ACETABULAR COMPONENT WAS EXPLANTED WITH THE SCREWS. 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 20239011 ↗
• InjurySep 12, 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 PERIPROSTHETIC JOINT INFECTION. DURING THE REVISION SURGERY, THE WHOLE PRIMARY THA SYSTEM WAS EXPLANTED AND REPLACED WITH A REDAPT MODULAR SHELL AND A REDAPT FEMORAL SYSTEM. AS REPORTED, WITHIN THE SAME MONTH AFTER THE SURGERY, THE PATIENT SUFFERED FROM DVT. THIS ADVERSE EVENT REQUIRED READMISSION TO THE HEALTH CARE FACILITY, BUT THERE IS NO INFORMATION AVAILABLE REGARDING HOW IT WAS TREATED. THERE IS NO FURTHER INFORMATION AT THIS TIME. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Swelling/ Edema

  MAUDE report 20208808 ↗
• InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT HIP REVISION SURGERY ON (B)(6) 2020 IN WHICH SMITH & NEPHEW WERE IMPLANTED; PATIENT SUSTAINED AN UNSPECIFIED INFECTION THAT REQUIRED A TWO-STAGE RE-REVISION SURGERY ON (B)(6) 2021. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 19554187 ↗
• InjuryJun 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER A RIGHT HIP REVISION SURGERY ON (B)(6) 2020 IN WHICH SMITH & NEPHEW WERE IMPLANTED; PATIENT SUSTAINED AN UNSPECIFIED MECHANICAL COMPLICATION OF INTERNAL RIGHT HIP PROSTHESIS THAT REQUIRED READMISSION ON (B)(6) 2020. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19553278 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE PMCF TITLED DCA-1000 ACCORD SS CLINICAL DATASET, IT WAS REPORTED THAT, AFTER UNDERGOING RIGHT THA, ONE (1) PATIENT EXPERIENCED CHRONIC HIP JOINT PAIN. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY COMBINED WITH INTERNAL FIXATION ON (B)(6) 2021, IN WHICH AN ACCORD CABLE SYSTEM WAS IMPLANTED. A POST-OPERATIVE FOLLOW-UP CONFIRMED A GOOD POSITION WITHOUT WEAR NOR EVIDENCE OF FAILURE.

  Patient problems: Bone Fracture(s); Implant Pain

  MAUDE report 16583163 ↗
• InjuryApr 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FLUID COLLECTION AND REVISION SURGERY WAS PERFORMED ON THE RIGHT HIP DUE TO CONTINUED ACCUMULATION OF FLUID. THE DEVICES WERE NOT EXPLANTED. THE OUTCOME OF THE PATIENT IS RESOLVED.

  Patient problems: Failure of Implant; Fluid Discharge; Swelling/ Edema

  MAUDE report 11744308 ↗

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.