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Modular Stem, 15-8522/58Recalls & reported problems

WALDEMAR LINK GmbH & Co. KG · Modular Stem, · 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 04026575383856), received between Mar 22, 2023 and Mar 22, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

16 other recalls cover devices cleared under the same FDA submission (K151008); 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

  • Loosening of Implant Not Related to Bone-Ingrowth1
  • Osseointegration Problem1

Patient problems

  • Failure of Implant1

Recent adverse event reports

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

  • InjuryMar 22, 2023Osseointegration Problem; Loosening of Implant Not Related to Bone-Ingrowth; Osseointegration Problem; Loosening of Implant Not Related to Bone-Ingrowth

    THE PATIENT REQUIRED REVISION SURGERY DUE TO LOOSENING OF FEMORAL STEM.

    Patient problems: Failure of Implant

    MAUDE report 16590435 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151008. One submission often covers many models, so check the product and lot details in each record.

  • Z-1520-2026 · Jan 12, 2026 · Open, Classified
    Endo-Model Replacement Plateau; Item Number: 15-8521/15;
  • Z-1518-2026 · Jan 12, 2026 · Open, Classified
    Endo-Model Replacement Plateau; Item Number: 15-8521/09;
  • Z-1516-2026 · Jan 12, 2026 · Open, Classified
    Endo-Model Replacement Plateau; Item Number: 15-2836/11;
  • Z-1517-2026 · Jan 12, 2026 · Open, Classified
    Endo-Model Replacement Plateau; Item Number: 15-8030/12;
  • Z-1511-2026 · Jan 12, 2026 · Open, Classified
    Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
  • Z-1515-2026 · Jan 12, 2026 · Open, Classified
    Endo-Model Replacement Plateau; Item Number: 15-2835/12;
  • Z-1514-2026 · Jan 12, 2026 · Open, Classified
    Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
  • Z-1521-2026 · Jan 12, 2026 · Open, Classified
    Endo-Model Replacement Plateau; Item Number: 15-0027/11;
  • Z-1512-2026 · Jan 12, 2026 · Open, Classified
    Endo-Model Replacement Plateau; Item Number: 15-0027/15;
  • Z-1519-2026 · Jan 12, 2026 · Open, Classified
    Endo-Model Replacement Plateau; Item Number: 15-8521/11;
  • Z-1523-2026 · Jan 12, 2026 · Open, Classified
    Endo-Model Replacement Plateau; Item Number: 15-0027/16;
  • Z-1522-2026 · Jan 12, 2026 · Open, Classified
    Endo-Model Replacement Plateau; Item Number: 15-0027/12;
  • Z-1513-2026 · Jan 12, 2026 · Open, Classified
    Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
  • Z-0890-2026 · Nov 10, 2025 · Open, Classified
    Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.
  • Z-2411-2024 · May 22, 2024 · Open, Classified
    Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial Component, Large, W: 75m

…and 1 more.

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