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CPCS 71312371Recalls & reported problems

Smith & Nephew, Inc. · CPCS COBALT CHROME PRIMARY HIGH OFFSET 12/14 TAPER SIZE 1 · Class 2 · Implant

Adverse event reports
4
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010462145), received between Jun 3, 2018 and Jul 4, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
  • Device Dislodged or Dislocated1
  • Loose or Intermittent Connection1
  • Unintended Movement1

Patient problems

  • Injury2
  • Insufficient Information1
  • Joint Dislocation1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER A THA SURGERY HAD BEEN PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT THAT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

    Patient problems: Insufficient Information

    MAUDE report 14911752 ↗
  • InjuryFeb 12, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

    IT WAS REPORTED THAT THE ORIGINAL THR WAS PERFORMED AT (B)(6) ON (B)(6) 2015. REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 DUE TO LOOSENING. THE STEM WAS EXPLANTED.

    Patient problems: Injury

    MAUDE report 9699347 ↗
  • InjuryNov 8, 2018Unintended Movement; Unintended Movement

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO POLY WEAR & STEM LOOSENING. X-RAYS AND NOTES NOT AVAILABLE. SURGEON DOES NOT BLAME DEVICE.

    Patient problems: Injury

    MAUDE report 8051809 ↗
  • InjuryJun 3, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

    REVISION SURGERY DUE TO RECURRENT DISLOCATION.

    Patient problems: Joint Dislocation

    MAUDE report 7564035 ↗

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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.