Quadra P femoral stems

Description of Event or Problem

The patient came in due to signs of infection and the pathogen is unknown. About 5 months after primary surgery, the surgeon performed a washout and revised all implants (stem, head, liner, cup) to new implants. The surgery was completed successfully.

Additional Manufacturer Narrative

Batch review performed on 20 July 2026 Stem: Quadra-P 01.12.126 Quadra-P Std. size 6 (K181254) Lot 2346500: (b)(4) items manufactured and released on 12-Apr-2024. Expiration date: 24-Mar-2029. 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: VersafitCup DM 01.26.2852MHC Double Mobility HC Liner D 28/DMF (K092265) Lot 2501254: (b)(4) items manufactured and released on 14-Mar-2025. Expiration date: 25-Feb-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: Versafitcup 01.26.52MB Versafitcup Metalback DM D 52 mm (K083116) Lot 2419207: (b)(4) items manufactured and released on 20-Nov-2024. Expiration date: 04-Nov-2029. 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. Ball Heads: MectaCer 01.29.202 MECTACER Head Biolox Delta dia.28 12/14-M (K112115) Lot 2529849: (b)(4) items manufactured and released on 09-Dec-2025. Expiration date: 18-Nov-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.