Mectacer Biolox Delta Femoral Ball Head

Description of Event or Problem

The patient had primary (no information available) and a first revision surgery in France (revision due toleft hip periprosthetic fracture for unknown reason; stem and head revised and fracture fixed with a plate). Presently, on (b)(6) 2026, about 2 weeks after the revision happened in France, the patient came in due to infection and the pathogen is unknown. The surgeon performed a washout, revised the competitor liner, and revised the head. The surgery was completed successfully.

Additional Manufacturer Narrative

Batch review performed on 20 July 2026 Lot 2600892: (b)(4) items manufactured and released on 11-Feb-2026. Expiration date: 20-Jan-2031. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review. Root cause: Infection is a known possible complication of any surgery. Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.