Megasystem C 15-8522/65Recalls & reported problems

WALDEMAR LINK GmbH & Co. KG · Stem Components,Coupling for dyaphyseal spacer · Class 2 · Implant

Data updated Oct 13, 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 04026575384068), received between May 7, 2024 and May 7, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Fracture1

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.

InjuryMay 7, 2024Fracture; Fracture
ULTIMATELY, ACCORDING TO THE DIAGNOSTIC REPORT, THE CONE OF THE PROXIMAL STEM WITH THE FEMORAL SHAFT DIAPHYSEAL PARTIAL REPLACEMENT ON THE RIGHT BROKE ON DECEMBER 8, 2023 WITHOUT EXTERNAL INFLUENCE AND SHOULD BE SENT TO YOU FOR EXAMINATION. ON (B)(6) 2023 MY RIGHT THIGH WAS FITTED WITH THE FOLLOWING PROSTHESIS MODEL FROM YOUR COMPANY LINK. STEM ELEMENT 100MM AND COUPLING PROXIMAL FEMUR LONG 30MM AND BODY 126° XXL 65MM WITH 20MM RECESS RING AND 61MM EXPANSION SCREW AS WELL AS L-HEAD 22MM CERAMIC AND CUP BI MOBILE 56MM. [EXCERPT FROM PATIENT LETTER].
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 19259021 ↗

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-1521-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-0027/11;
Z-1520-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-8521/15;
Z-1519-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-8521/11;
Z-1517-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-8030/12;
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-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-1518-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-8521/09;
Z-1513-2026 · Jan 12, 2026 · Open, Classified
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
Z-1522-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-0027/12;
Z-1511-2026 · Jan 12, 2026 · Open, Classified
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
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.

Device details

UDI-DI	`04026575384068`
Brand	Megasystem C
Model	15-8522/65
Company	WALDEMAR LINK GmbH & Co. KG
Product code	LWJ · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Class	Class 2
FDA submission	K151008
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 6, 2018

Device type (GMDN): Diaphysis prosthesis

An artificial substitute for the diaphysis (shaft) of a humerus, femur, or tibia intended to be implanted for the long-term stabilization of segmental bone defects (e.g., due to osteomyelitis, trauma, bone tumours, or non-healed fractures after osteosynthesis/revision arthroplasty). It is a modular device that typically includes a resection element (spacer), intramedullary nails (inserted into the intramedullary canal), screws, and connectors all made of metal [e.g., titanium (Ti)]; components are both sterile and non-sterile. Instruments for implantation are typically included and implantation may be performed with or without bone cement.

Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented devices

LFIT 6260-9-136
Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented
166 reports
Trident 623-00-36E
Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented
112 reports
Accolade 6021-0435
Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented
88 reports
EXETER 0580-1-044
Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented
1 recall22 reports
Endo-Model SL Knee Prosthesis System 16-2840/02
WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
1 recall17 reports
Endo-Model SL Knee Prosthesis System 16-2840/05
WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
1 recall12 reports
Trident 623-10-36E
Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented
57 reports
LFIT 6260-9-336
Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented
56 reports

All Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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