SPII Model Lubinus 127-922/35Recalls & reported problems

WALDEMAR LINK GmbH & Co. KG · XL Hip Prosthesis Stem,Taper 12/14 · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026575025244), received between Jun 6, 2024 and Jun 6, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

4 other recalls cover devices cleared under the same FDA submission (K953653); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

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

Recalls naming this device

Feb 6, 2024Class IIOpen, Classified
Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
Z-1298-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Device problems

Fracture1
Loosening of Implant Not Related to Bone-Ingrowth1

Patient problems

Bone Fracture(s)1
Failure of Implant1
Periprosthetic fracture1

Recent adverse event reports

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

InjuryJun 6, 2024Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth
FRACTURE OF THE PROSTHESIS STEM [CUSTOMER].
Patient problems: Bone Fracture(s); Failure of Implant; Periprosthetic fracture
MAUDE report 19475314 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K953653. One submission often covers many models, so check the product and lot details in each record.

Z-2288-2025 · Jul 15, 2025 · Open, Classified
Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
Z-1296-2024 · Feb 6, 2024 · Open, Classified
SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented
Z-1299-2024 · Feb 6, 2024 · Open, Classified
SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented
Z-1297-2024 · Feb 6, 2024 · Open, Classified
SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented

Device details

UDI-DI	`04026575025244`
Brand	SPII Model Lubinus
Model	127-922/35
Company	WALDEMAR LINK GmbH & Co. KG
Product code	JDG · Prosthesis, Hip, Femoral Component, Cemented, Metal
Class	Class 2
FDA submission	K953653
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): Revision uncoated hip femur prosthesis

A sterile device designed to replace the entire femoral component of a total hip prosthesis implanted during replacement of the total hip prosthesis typically due to wear. The revision device is composed of two or more separate segments (e.g., femoral head, neck, stem, and extensions) designed to be joined (modular) and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with bone cement.

Other Prosthesis, Hip, Femoral Component, Cemented, Metal devices

GENESIS II 71440005
Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal
599 reports
NA 71364073
Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal
436 reports
Peri-Loc 71173377
Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal
401 reports
R3 71368569
Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal
398 reports
NA 71364006
Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal
197 reports
NA 71364011
Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal
176 reports
Accord 71360046
Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal
171 reports
REFLECTION 71362279
Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal
155 reports

All Prosthesis, Hip, Femoral Component, Cemented, Metal 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 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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