Mectacer Biolox Delta Femoral Ball Head

Description of Event or Problem

Revision surgery was performed one month after the primary procedure due to a risk of dislocation during hip flexion. The surgeon revised the head and the liner. The procedure was completed successfully.

Additional Manufacturer Narrative

Batch review performed on 21 July 2026 01.29.204 MECTACER Head Biolox Delta dia.32 12/14-S (K112115) Lot. 2529444: (b)(4) items manufactured and released on 28 November 2025. Expiration date: 16 November 2030. 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. 01.32.3239HCT Flat PE HC liner D 32/C (K103721) Lot. 2514638: (b)(4) items manufactured and released on 29 July 2025. Expiration date: 09 July 2030. 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:Based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.