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BIOLOX delta 71325152Recalls & reported problems

Smith & Nephew, Inc. · R3 36MM ID US DELTA LINER 52MM OD · Class 3 · Implant

All models of BIOLOX delta (11)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 00885556498644), received between Sep 20, 2020 and Sep 20, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

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.

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available1
  • Loose or Intermittent Connection1

Patient problems

  • Injury1
  • Pain1

Recent adverse event reports

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

  • InjurySep 20, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY OPERATION ON (B)(6) 2019 AND PRESENTED GROIN PAIN SINCE THAT. X-RAYS WERE TAKEN AND SHOW MOVEMENT-LOOSENING OF STEM. REVISION SURGERY WAS PERFORMED AND STEM-HEAD WAS REMOVED.

    Patient problems: Injury; Pain

    MAUDE report 10558257 ↗

Other Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented devices

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Sources and updates

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