MalfunctionJDG

PROSTHESIS HEADS B

Received Jun 12, 2026 · Event occurred May 15, 2026

Report 3004371426-2026-00048 · MDR key 25481902

Device

Generic name

Prosthesis Head B, Ø 36 Mm, Neck L= M, 0 Mm, Taper 12/14, Cocrmo

Manufacturer

Waldemar Link Gmbh & Co. Kg

Model number

128-836/02

Catalog number

128-836/02

Product problems

Unsealed Device Packaging

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO DEVIATIONS. THE PRODUCT COMPLIES WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURE. THE WALDEMAR LINK GMBH & CO. KG WAS FIRST NOTIFIED ABOUT THE INCIDENT ON (B)(6) 2026. HOWEVER, CRUCIAL INFORMATION REGARDING THE CRITICALITY OF THE EVENT WAS AVAILABLE TO WALDEMAR LINK GMBH & CO. KG FROM (B)(6) 2026.

Description of Event or Problem

DEFECT IN SEALED EDGE IN OUTER PLASTIC PACKAGE [CUSTOMER].