UNK Head
Received Jul 31, 2026
Report 0001825034-2026-02234 · MDR key 50097660
Device
Product problems
- Material Erosion
Patient
Not reported
- Fall
- Bone Fracture(s)
- Memory Loss/Impairment
- Necrosis
- Pain
- Retinal Detachment
- Scar Tissue
- Loss of Vision
- Deformity/ Disfigurement
- Cancer
- Unspecified Heart Problem
- Partial Hearing Loss
- Metal Related Pathology
Narrative
Description of Event or Problem
It was reported that beginning approximately three years post- hip implantation with metal on metal prosthesis, the patient has experienced metallosis. The patient has experienced vision loss with near-blindness, retinal detachment, hearing loss, pain, tissue necrosis, myocardial injury to heart, memory problems, scarring, deformity, pseudotumors, unknown bone fracture, difficulty walking, falling, cancer. It is unknown if there has been treatment or intervention.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).H6: Proposed component code: Mechanical (G04) - head.The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental MedWatch 3500A will be submitted.