BUCK 129419Recalls & reported problems
Smith & Nephew, Inc. · BUCK FEMORAL CEMENT RESTRICTOR 25MM · Class 2 · Implant
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 03596010086440), received between Jul 27, 2022 and Apr 2, 2026 — 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 (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. 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
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
Patient problems
- Aseptic loosening1
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, PATIENT EXPERIENCED ASEPTIC LOOSENING. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2026, DURING WHICH, THE BUCK FEM CEMENT RSTR 25MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH CONDITION IS UNKNOWN.
Patient problems: Aseptic loosening
MAUDE report 24761596 ↗InjuryJul 27, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, THE PLASTIC FLANGE OF A BUCK FEMORAL CEMENT RESTRICTOR 25MM BROKE OFF AFTER THE IMPLANT WAS CEMENTED INTO THE PATIENT'S CANAL. THE BROKEN PIECE WAS REMOVED AND THE REMAINING MAIN PIECE WAS LEFT IN THE PATIENT SINCE IT WAS ALREADY CEMENTED. SO, SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 15117325 ↗
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
- ACM BioPrep 0306705000Stryker Corporation · CEMENT OBTURATOR1 recall0 reports
- NA 0306703000Stryker Corporation · CEMENT OBTURATOR1 recall0 reports
- BIOSTOP 5463-20-000Depuy Orthopaedics, Inc. · CEMENT OBTURATOR1 recall0 reports
- PREP-IM 121010Smith & Nephew, Inc. · CEMENT OBTURATOR10 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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