NA 71336520Recalls & reported problems
Smith & Nephew, Inc. · UNIVERSAL CANCELLOUS ACETABULAR SCREW 20MM · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010197658), received between Nov 13, 2018 and Sep 27, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Inaccurate Information” (1 report).
1 other recall cover devices cleared under the same FDA submission (K211176, K920430); 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
- Inaccurate Information1
- Positioning Problem1
Patient problems
- Injury1
- 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.
MalfunctionSep 27, 2021Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT, AFTER SURGERY WAS COMPLETED, IT WAS FOUND THAT THE CONTENT OF THE MAIN CODE (01) FIELD IN THE ENGLISH LOGO OF THE UNIV CAN ACET SCREW 20MM WAS "0", WHICH WAS INCONSISTENT WITH THE CONTENT OF THE PRODUCT (01) FIELD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12537703 ↗InjuryNov 13, 2018Positioning Problem; Positioning Problem
IT WAS REPORTED THAT ONE MONTH AFTER SURGERY, IN THE REVIEW, IT WAS FOUND THAT ONE ACETABULAR SCREW WAS COMPLETELY THROUGH AND OUT OF THE ACETABULAR CAVITY.
Patient problems: Injury
MAUDE report 8064371 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K211176, K920430. 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, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 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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