Mectacer Biolox Delta Femoral Ball Head

Description of Event or Problem

The patient came in presenting pain and the cause is unknown. At 5 months post primary the surgeon revised the Medacta cup and liner to a competitor cup and liner and revised the 32mm BIOLOX Delta Head M to a 28mm BIOLOX Option Head with M sleeve. The surgery was completed successfully.

Additional Manufacturer Narrative

Batch review performed on 22 July 2026: Ball Heads: MectaCer 01.29.205 MECTACER Head Biolox Delta dia.32 12/14-M (K112115) Lot 2525187: (b)(4) items manufactured and released on 09-Oct-2025. Expiration date: 24-Sep-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. Liner: MPACT 01.32.3241HCT Flat PE HC liner D 32/D (K103721) Lot 2504978: (b)(4) items manufactured and released on 4-Jul-2025. Expiration date: 16-Jun-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. Cup: MPACT 01.32.148DHT Acetabular shell D 48 Two-holes T (K250450) Lot 2521024: (b)(4) items manufactured and released on 21-Oct-2025. Expiration date: 13-Oct-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 for the reported pain and subsequent revision can be established. The batch record review did not identify any potentially related manufacturing issue, and no similar events were reported for the involved lots during the period reviewed. Therefore, there is no indication that a device-related issue caused or contributed to the event.