BUCK 129418Recalls & reported problems
Smith & Nephew, Inc. · BUCK FEMORAL CEMENT RESTRICTOR 18.5MM · Class 2 · Implant
- 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 03596010086433), received between Mar 30, 2026 and Mar 30, 2026 — classified as 1 injury.
1 other recall cover devices cleared under the same FDA submission (K211176, K791125); 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Medical device site infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A THR SURGERY, PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON AN UNKNOWN DATE, DURING WHICH, THE BUCK CEMENT RSTR 18.5 WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Medical device site infection
MAUDE report 24720801 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K211176, K791125. 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 CEMENT OBTURATOR devices
- BIOSTOP 5463-12-000Depuy Orthopaedics, Inc. · CEMENT OBTURATOR1 recall6 reports
- BIOSTOP 5463-08-000Depuy Orthopaedics, Inc. · CEMENT OBTURATOR1 recall1 report
- BIOSTOP 5463-16-000Depuy Orthopaedics, Inc. · CEMENT OBTURATOR1 recall1 report
- BIOSTOP 5463-18-000Depuy Orthopaedics, Inc. · CEMENT OBTURATOR1 recall1 report
- NA 0306703000Stryker Corporation · CEMENT OBTURATOR1 recall0 reports
- ACM BioPrep 0306705000Stryker Corporation · CEMENT OBTURATOR1 recall0 reports
- BIOSTOP 5463-20-000Depuy Orthopaedics, Inc. · CEMENT OBTURATOR1 recall0 reports
- PREP-IM 121010Smith & Nephew, Inc. · CEMENT OBTURATOR10 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.