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COBRA 71312161Recalls & reported problems

Smith & Nephew, Inc. · COBRA PRIMARY STANDARD OFFSET 12/14 SIZE 1 · 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 03596010443045), received between Jan 27, 2021 and Jan 27, 2021 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K211176, K970351); 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

Patient problems

  • Failure of Implant1
  • Joint Dislocation1
  • Metal Related Pathology1
  • Pain1
  • Pocket Erosion1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENT LEFT HIP ON (B)(6) 2020. THE REVISION SURGERY WAS PERFORMED DUE TO INCREASINGLY PAINFUL LEFT HIP; FAILED LEFT REVISION TOTAL HIP REPLACEMENT WITH EXTENSIVE METALLOSIS AND RECURRENT DISLOCATIONS. THE PATIENT´S FIRST DISLOCATION OCCURRED ON (B)(6) 2019 AND WAS TREATED VIA OPEN REDUCTION. THE SECOND DISLOCATION OCCURRED ON (B)(6) 2019 AND WAS TREATED VIA CLOSED REDUCTION. DURING THE REVISION SURGERY, ALL THE THA COMPONENTS WERE EXPLANTED AND REPLACED WITH A SYSTEM FROM A COMPETITOR. THE PATIENTS¿ OUTCOME IS UNKNOWN

    Patient problems: Failure of Implant; Joint Dislocation; Metal Related Pathology; Pain; Pocket Erosion

    MAUDE report 11240787 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211176, K970351. 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.