REDAPT 71354844Recalls & reported problems
Smith & Nephew, Inc. · REDAPT 300MM SLEEVED REVISION STEM SIZE 19 STANDARD OFFSET · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556580295), received between Sep 24, 2021 and Sep 24, 2021 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hematoma1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 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, AFTER A MEDICALLY INDICATED REVISION OF RIGHT HIP THA PERFORMED ON (B)(6) 2020, WHERE REDAPT SLVD MONO STEM 300MM SZ 19 SO WAS IMPLANTED, A SECOND REVISION SURGERY WAS NECESSARY DUE TO AN UNSPECIFIED INFECTION. AN HEMATOMA WAS ALSO REPORTED TO BE DRAINED. ADDITIONAL DETAILS ABOUT PRIMARY SURGERY AND THE PATIENT'S FINAL OUTCOME ARE 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: Hematoma; Unspecified Infection
MAUDE report 12524189 ↗
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, ClassifiedTandem 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.
Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate devices
- Novation 130-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls156 reports
- Novation 130-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls79 reports
- CORAIL 3L92511Depuy (Ireland) · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate158 reports
- Acumatch A Series 138-36-29Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 recalls1 report
- Novation 136-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls43 reports
- Novation 130-32-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls33 reports
- Novation 132-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls26 reports
- Novation 136-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls22 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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