Mectacer Biolox Delta Femoral Ball Head

Description of Event or Problem

Revision surgery after 1 month from the primary due to infection.The surgeon performed a washout, revised the head and liner, and added a sleeve. The surgery was completed successfully.

Additional Manufacturer Narrative

Batch review performed on 23 July 2026 01.29.204 MECTACER Head Biolox Delta dia.32 12/14-S (K112115) Lot. 2608254: (b)(4) items manufactured and released on 15 April 2026. Expiration date: 26 March 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. 01.32.3241HCT Flat PE HC liner D 32/D (K103721) Lot. 2532093: (b)(4) items manufactured and released on 15 January 2026. Expiration date: 11 December 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: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.