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Gemini SL 318-103/03Recalls & reported problems

WALDEMAR LINK GmbH & Co. KG · Femoral Component · Class 2 · Implant

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 04026575311392), received between Feb 1, 2023 and Feb 1, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Degraded” (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

  • Degraded1
  • Loosening of Implant Not Related to Bone-Ingrowth1

Patient problems

  • Failure of Implant1
  • Insufficient Information1

Recent adverse event reports

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

  • InjuryFeb 1, 2023Degraded; Loosening of Implant Not Related to Bone-Ingrowth; Degraded; Loosening of Implant Not Related to Bone-Ingrowth

    ASEPTIC MOBILIZATION LEFT TOTAL KNEE REPLACEMENT.

    Patient problems: Failure of Implant; Insufficient Information

    MAUDE report 16277024 ↗

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices →

Sources and updates

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