Quadra H femoral stems

Description of Event or Problem

Revision surgery after 5 years and 9 months due to stem loosening. The surgeon revised all the components.

Additional Manufacturer Narrative

Batch review performed on 15 July 2026 01.12.022 QUADRA Stem Standard HAP 12/14 S.2 (K082792) Lot. 2000251: (b)(4) items manufactured and released on 25 May 2020. Expiration date: 12 May 2025. No anomalies reported. To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review. Clinical evaluation A revision surgery was performed approximately five years and nine months after the primary cementless THA due to loosening of the femoral stem. The available radiograph shows the stem in generally satisfactory alignment, without evident fracture or gross malposition. However, radiolucent changes around the proximal femoral component and limited apparent contact with the surrounding bone are compatible with impaired biological fixation. The photograph of the retrieved stem shows little visible adherent bone on the coated surface, which further supports incomplete or lost osseointegration. The acetabular component was retained, and the ceramic liner was exchanged only according to surgeon preference; therefore, no acetabular failure is indicated. In the absence of immediate postoperative and serial follow-up radiographs, the initial stem fit and the evolution of fixation cannot be assessed. Aseptic loosening is a known, often multifactorial complication of cementless THA. The precise cause remains undetermined, and there are no elements to suggest a defective or malfunctioning device. R&D Analysis From the informations and the images reported it is visible the explated stems togheter with ceramic cup and liner. Looking at the stem body some opaque white spots are visible on the stem length. It is not possible to identify if this film is HA or bone residual, or a combined effect. Absorption of HA from the stem body can indicate that metabolic activity was taking place and that, presumably, adequate bone contact was achieved at the time of surgery. The post-op X-Ray analysis could possibly provide more insight, such as the evaluation of possible early rotational instability or initial stress-shielding. Some signs of minor damage and scratches are present on the neck of the explanted stem, which is likely due to the revision surgery and not relevant to the reported issue. Based on the analysis completed and information available, it is not possible to identify a root cause of the stem loosening reported. Root cause:Based on the information available, the reported stem loosening appears to be related to insufficient or subsequently lost biological fixation. The batch review did not identify any potentially related manufacturing anomaly, and no definitive device-related root cause could be established.