REDAPT 71354465Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556580592), received between Sep 23, 2021 and Sep 24, 2021 — classified as 3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AS PART OF AN UNSPECIFIED MEDICAL INDICATION, A PATIENT UNDERWENT A THR REVISION SURGERY ON THE LEFT HIP ON (B)(6) 2016. DURING THIS PROCEDURE, A REDAPT SLVLS MONO STEM 190MM SZ 16 SO WAS IMPLANTED. IN THE FIRST FOLLOW UP (3 WEEKS POSTOP), A TROCHANTERIC FRACTURE WAS FOUND. IT IS UNKNOWN IF THE TROCHANTERIC FRACTURE INTRAOPERATIVELY OR AFTER THE PROCEDURE. IT IS UNKNOWN IF/HOW THE ADVERSE EVENT WAS TREATED. 4 MONTHS POSTOPERATIVELY, THE PATIENT REPORTED STIFFNESS AND PAIN. ADDITIONAL DETAILS ABOUT THE IMPLANTED PROSTHESIS BEFORE THE FIRST REVISION SURGERY WAS PERFORMED ARE NOT AVAILABLE. AFTER THIS ADVERSE EVENT THE PATIENT SUFFERED FROM AN OSTEOMYELITIS (COVERED UNDER (B)(4)) AND A DVT (COVERED UNDER ((B)(4)). AS THE DATA COLLECTION HAS BEEN DONE RETROSPECTIVELY AND IS ANONYMIZED, FURTHER DETAILS ON THE PATIENT'S FINAL OUTCOME ARE UNKNOWN.

  Patient problems: Arthralgia; Bone Fracture(s); Failure of Implant; Loss of Range of Motion; Osteomyelitis; Pain; Thrombosis/Thrombus

  MAUDE report 12529547 ↗
• InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AS PART OF AN UNSPECIFIED MEDICAL INDICATION, A PATIENT UNDERWENT A THR REVISION SURGERY ON THE LEFT HIP ON (B)(6) 2016. DURING THIS PROCEDURE, A REDAPT SLVLS MONO STEM 190MM SZ 16 SO WAS IMPLANTED 10 MONTHS POSTOPERATIVELY, AN OSTEOMYELITIS DUE TO ENTEROCOCCUS INFECTION WAS REPORTED TO OCCUR. A REVISION SURGERY WAS PERFORMED TO TREAT THIS ADVERSE EVENT (COVERED UNDER (B)(4)). AFTER THE REVISION SURGERY PERFORMED DUE TO OSTEOMYELITIS, THE PATIENT DEVELOPED A CHRONIC DEEP VEIN THROMBOSIS AND A SMALL SUPERFICIAL SUBCUTANEOUS MASS WITH QUESTIONABLE INTERNAL VASCULARITY. SINCE IT IS UNKNOWN IF THE REDAPT SLVLS MONO STEM 190MM SZ 16 SO WAS EXPLANTED OR NOT DURING THE SECOND REVISION SURGERY, THE CONTRIBUTION OF THIS DEVICE TO THE REPORTED EVENT COULD NOT BE DISCARDED. FURTHER DETAILS ON THE PATIENT'S FINAL OUTCOME ARE UNKNOWN. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET SURVEILLANCE (PMS) WHERE ANONYMIZED DATA SUMMARIZING OUTCOMES WERE GATHERED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN AND IT IS NOT POSSIBLE TO COLLECT IT.

  Patient problems: Bacterial Infection; Osteomyelitis; Thrombosis/Thrombus

  MAUDE report 12524160 ↗
• InjurySep 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AS PART OF AN UNSPECIFIED MEDICAL INDICATION, A PATIENT UNDERWENT A THR REVISION SURGERY ON THE LEFT HIP ON (B)(6) 2016. DURING THIS PROCEDURE, A REDAPT SLVLS MONO STEM 190MM SZ 16 SO WAS IMPLANTED. 10 MONTHS POSTOPERATIVELY, AN OSTEOMYELITIS DUE TO ENTEROCOCCUS INFECTION WAS REPORTED TO OCCUR. A REVISION SURGERY WAS PERFORMED TO TREAT THIS ADVERSE EVENT. THE PATIENT WAS TREATED WITH THE ADDITIONAL ADMINISTRATION OF IV ABX. AFTER THE REVISION, THE PATIENT DEVELOPED A DVT. ADDITIONAL DETAILS ABOUT THE IMPLANTED PROSTHESIS BEFORE THE FIRST REVISION SURGERY WAS PERFORMED ARE NOT AVAILABLE. AS THE DATA COLLECTION HAS BEEN DONE RETROSPECTIVELY AND IS ANONYMIZED, FURTHER DETAILS ON THE PATIENT'S FINAL OUTCOME ARE UNKNOWN.

  Patient problems: Osteomyelitis

  MAUDE report 12523845 ↗

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.