Modular Stem, 15-8522/57Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026575383849), received between Feb 16, 2024 and Feb 16, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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

Recent adverse event reports

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

• InjuryFeb 16, 2024Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Osseointegration Problem; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Osseointegration Problem

  INFORMATION RECEIVED FROM SURGEON (B)(6) 2024 SUGGESTS THAT THE DESIGN OF THIS CONE AND STEM CONSTRUCT MAY NOT HAVE BEEN WELL SUITED FOR THIS PATIENT: THE SURGEON NOTED ON (B)(6) 2024 THAT THE WL CONES ADDRESS METAPHYSEAL AREA BUT DO NOT ADDRESS META-DIAPHYSEAL INGROWTH, ESPECIALLY WHEN USED WITH CEMENTLESS STEMS (AS IN THIS CASE). THE SUBJECT COMPONENTS WERE IMPLANTED BY DR. (B)(6) DURING REVISION KNEE SURGERY ON (B)(6) 2022. PATIENT COMPLAINED OF PAIN LOCATED IN MEDIAL AND LATERAL RIGHT KNEE STARTING AFTER SURGERY. DUE TO PAIN AND FEMORAL STEM LOOSENING, THE PATIENT'S KNEE WAS REVISED ON (B)(6) 2024. FEMORAL SIDE IMPLANTS WERE REPLACED WITH CUSTOM-MADE FEMORAL STEM (LBIO REF: CUS-736, WL REF: (B)(4)), AND STANDARD ITEMS 15-8521/10 (TOTAL CONDYLAR REPLACEMENT) AND 15-0027/15 (REPLACEMENT PLATEAU). [CUSTOMER].

  Patient problems: Failure of Implant; Pain

  MAUDE report 18719245 ↗

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-1523-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-0027/16;
• Z-1515-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-2835/12;
• Z-1522-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-0027/12;
• Z-1518-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-8521/09;
• Z-1511-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
• Z-1521-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-0027/11;
• Z-1517-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-8030/12;
• Z-1512-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-0027/15;
• Z-1516-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-2836/11;
• Z-1513-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
• Z-1519-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-8521/11;
• Z-1514-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
• 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.