Prosthesis Head B 128-832/01Recalls & reported problems
WALDEMAR LINK GmbH & Co. KG · Modular Prosthesis Head,CoCrMo · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04026575365166), received between Mar 4, 2026 and May 7, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Unsealed Device Packaging” (2 reports).
5 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Unsealed Device Packaging2
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 7, 2026Unintended Movement
THE ENTIRE SCREW, INCLUDING THE HEAD, SLIPPED THROUGH THE HOLE IN THE CUP. [CUSTOMER]
Patient problems: Pain
MAUDE report 25108420 ↗MalfunctionApr 30, 2026Unsealed Device Packaging
DEFECT IN SEALED SEAM OF THE OUTER STERILE POUCH [CUSTOMER].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25041903 ↗MalfunctionMar 4, 2026Unsealed Device Packaging
DEFECT IN SEALED EDGE IN OUTER PLASTIC PACKAGE (CUSTOMER).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24510962 ↗
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, ClassifiedProsthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
- Z-1299-2024 · Feb 6, 2024 · Open, ClassifiedSPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented
- Z-1296-2024 · Feb 6, 2024 · Open, ClassifiedSPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented
- Z-1297-2024 · Feb 6, 2024 · Open, ClassifiedSPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented
- Z-1298-2024 · Feb 6, 2024 · Open, ClassifiedSPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented
Other Prosthesis, Hip, Femoral Component, Cemented, Metal devices
- GENESIS II 71440005Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal599 reports
- NA 71364073Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal436 reports
- Peri-Loc 71173377Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal401 reports
- R3 71368569Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal398 reports
- NA 71364006Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal197 reports
- NA 71364011Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal176 reports
- Accord 71360046Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal171 reports
- REFLECTION 71362279Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal155 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.