Mectacer Biolox Delta Femoral Ball Head

Description of Event or Problem

The patient had a hip infection and the pathogen is unknown. At about 20 days from primary the surgeon performed a washout and revised the Flat PE HC liner D 36/F and 36mm BIOLOX Delta Head M to a same size liner and head. The surgery was completed successfully.

Additional Manufacturer Narrative

Batch review performed on 22 July 2026: Ball Heads: MectaCer 01.29.209 MECTACER Head Biolox Delta dia.36 12/14-M (K112115) Lot. 2604861: (b)(4) items manufactured and released on 18-Mar-2026. Expiration date: 02-Mar-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. Liner: MPACT 01.32.3648HCT Flat PE HC liner Ø36/F (K103721) Lot. 2532101: (b)(4) items manufactured and released on 29-Jan-2026. Expiration date: 07-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. Reboot 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.