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CPCS 71928846Recalls & reported problems

Smith & Nephew, Inc. · CPCS COBALT CHROME PRIMARY STANDARD OFFSET 12/14 XSM · Class 2 · Implant

Data updated Oct 13, 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 03596010473400), received between Jul 15, 2018 and Sep 22, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 other recall cover devices cleared under the same FDA submission (K211176, K823727); 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
  • Insufficient Device Problem Information1

Patient problems

  • Failure of Implant1
  • Insufficient Information1
  • Unspecified Infection1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER A THR, A REVISION SURGERY WAS PERFORMED IN TWO STAGES, THE FIRST STAGE ON (B)(6) 2021 AND THE SECOND STAGE ON (B)(6) 2021. IN THE SECOND STAGE REVISION SURGERY, NINE (9) DEVICES WERE EXPLANTED, A REF XLPE ALL PLY CUP 36 52, A COCR 12/14 FEM HEAD 36MM +8, A CPCS PRI STD OFFSET 12/14 XSM, A ACC STD 125MM 5 CBL TROCH GRIP, A ACCORD 2.0MM COCR CABLE, AND FOUR (4) ACC 2.0MM COCR CABLES W/CLAMP. THE REASON TO PERFORM THE REVISION SURGERY AND THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

    Patient problems: Failure of Implant; Insufficient Information

    MAUDE report 12516550 ↗
  • InjuryJul 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION.

    Patient problems: Unspecified Infection

    MAUDE report 7688806 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211176, K823727. One submission often covers many models, so check the product and lot details in each record.

  • Z-0326-2025 · Oct 15, 2024 · Open, Classified
    Tandem 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

All Prosthesis, hip, semi-constrained, metal/polymer, cemented devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page