REDAPT 71354467Recalls & reported problems
Smith & Nephew, Inc. · REDAPT 190MM SLEEVELESS REVISION STEM SIZE 18 STANDARD OFFSET · Class 2 · Implant
All models of REDAPT (89)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556580615), received between Sep 23, 2019 and Nov 28, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Insufficient Device Problem Information1
Patient problems
- Unspecified Infection2
- Bone Fracture(s)1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 28, 2023Fracture; Fracture
IT WAS REPORTED THAT, AFTER THR SURGERY WAS PERFORMED ON (B)(6) 2023, SUBSIDENCE WAS DETECTED IN THE PATIENT AS RESULT OF POSSIBLE INFECTION AND MEDIAL CALCAR FRACTURE. THIS ADVERSE EVENT WAS TREATED BY PERFORMING STEM REVISION SURGERY ON (B)(6) 2023. PATIENT'S OUTCOME IS UNKNOWN.
Patient problems: Bone Fracture(s); Unspecified Infection
MAUDE report 18223315 ↗InjurySep 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. LYSIS WAS NOTED AT THE BACK OF THE CUP AND A MEMBRANE WAS FORMED AROUND STEM.
Patient problems: Unspecified Infection
MAUDE report 9105717 ↗
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, 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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