REDAPT 71354805Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556579947), received between Sep 24, 2021 and Apr 19, 2024 — classified as 4 injuries.

1 other recall cover devices cleared under the same FDA submission (K162303, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FORTY-FOUR (44) MONTHS AFTER A RIGHT THA RE-REVISION PERFORMED ON AN UNKNOWN DATE DUE TO POST TRAUMATIC ARTHRITIS FROM A MOTOR VEHICLE ACCIDENT, THE PATIENT REQUIRED AN ADDITIONAL SURGERY TO REMOVE THE IMPLANTS DUE TO TROCHANTERIC BURSITIS. A BURSECTOMY WAS PERFORMED TO TREAT THIS ADVERSE EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bursitis

  MAUDE report 19149318 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THA RE-REVISION PERFORMED ON AN UNKNOWN DATE DUE TO POLY WEAR, LYSIS AND LOOSENING, THE PATIENT WAS ADMITTED TO THE ER ON (B)(6) 2019 DUE TO INCREASED SWELLING TO RIGHT TIGHT, BRUISING AND DRAINAGE AROUND INCISION. DVT DIAGNOSIS WAS RULED OUT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Easy Bruising; Swelling/ Edema

  MAUDE report 19148956 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A RIGHT THA RE-REVISION PERFORMED ON AN UNKNOWN DATE DUE TO POLY WEAR, LYSIS AND LOOSENING, THE PATIENT SUSTAINED A MEDIAL FRACTURE DURING THE TROCHANTERIC OSTEOTOMY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 19148764 ↗
• InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER MEDICALLY INDICATED REVISION OF THE RIGHT TOTAL HIP, PERFORMED ON (B)(6) 2018, WHERE REDAPT SLVD MONO STEM 240MM SZ 16 SO WAS IMPLANTED, PATIENT EXPERIENCED SKIN EDGE NECROSIS AROUND THE INCISION WOUND AND WAS PLACED ON KEFLEX AS A PROPHYLACTIC TREATMENT. TWO MONTHS LATER EVIDENCE OF NON UNION WAS FOUND ON X-RAYS, BUT NO SURGICAL INTERVENTION WAS PERFORMED. AN INFECTION WAS SUSPECTED ON 18-JUL-2018 AND INCISION AND DRAINAGE WAS PERFORMED. IT IS UNKNOWN IF ANY ADDITIONAL INTERVENTIONS OR REVISION WERE PERFORMED. ADDITIONAL DETAILS ABOUT PRIMARY SURGERY ARE UNKNOWN. PATIENT OUTCOME IS UNKNOWN. THIS DE-IDENTIFIED CLINICAL DATA IS RELATED TO A POST MARKET CLINICAL FOLLOW-UP ACTIVITY FOR REDAPT SLEEVED MONO STEMS. AS THE DATA COLLECTION ACTIVITY HAS BEEN DONE RETROSPECTIVELY AND DATA IS PROVIDED ANONYMIZED, THE INFORMATION PROVIDED IS LIMITED AND FURTHER INFORMATION CANNOT BE OBTAINED.

  Patient problems: Necrosis; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 12524238 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162303, 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.