REDAPT 71354483Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556580776), received between Sep 24, 2021 and Sep 29, 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 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 RIGHT HIP ON (B)(6) 2018. DURING THIS PROCEDURE, A REDAPT SLVLS MONO STEM 190MM SZ 16 HO WAS IMPLANTED. 1 YEAR POSTOPERATIVELY, THE PATIENT UNDERWENT A SECOND REVISION SURGERY DUE TO A DISLOCATION FOLLOWING A FALL. IT IS UNKNOWN WHICH DEVICES WERE EXPLANTED AND WHICH DEVICES WERE IMPLANTED IN EXCHANGE. THE CONTRIBUTION OF REDAPT SLVLS MONO STEM 190MM SZ 16 HO TO THE REPORTED ADVERSE EVENT COULD NOT BE DISCARDED AT THIS TIME. ADDITIONAL DETAILS ABOUT THE IMPLANTED PROSTHESIS BEFORE THE SECOND 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: Fall; Joint Dislocation

  MAUDE report 12548864 ↗
• 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 RIGHT HIP ON (B)(6) 2017. DURING THIS PROCEDURE, A REDAPT SLVLS MONO STEM 190MM SZ 16 HO WAS IMPLANTED. 1 WEEK POSTOPERATIVELY, A SUPERFICIAL SEROMA POPPED AFTER RELEASING THE SUTURES AND WAS DRAINED THROUGH A DEHISCENCE 3CM DISTAL FROM INCISION SITE. ADDITIONAL DETAILS ABOUT THE IMPLANTED PROSTHESIS BEFORE THE 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: Pain; Seroma; Wound Dehiscence

  MAUDE report 12524132 ↗
• 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 RIGHT HIP ON (B)(6) 2016. DURING THIS PROCEDURE, A REDAPT SLVLS MONO STEM 190MM SZ 16 HO WAS IMPLANTED. AFTER THIS PROCEDURE, THE PATIENT REPORTED JOINT INSTABILITY EPISODES WHICH LED TO A SECOND REVISION SURGERY BEEN PERFORMED ON (B)(6) 2017. THE CONTRIBUTION OF REDAPT SLVLS MONO STEM 190MM SZ 16 HO TO THE REPORTED EVENT COULD NOT BE DISCARDED AT THIS TIME. 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: Insufficient Information; Joint Laxity

  MAUDE report 12524131 ↗

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.