Quadra H femoral stems

Description of Event or Problem

Revision surgery due to stem loosening after about 9 years and 7 months from primary.The surgeon revised stem and head to competitor devices.

Additional Manufacturer Narrative

Clinical evaluation The available radiograph shows a well-aligned femoral stem, revised after 10 years. However, the stem appears relatively small in relation to the femoral canal, and an extensive area of proximal bone rarefaction or possibly osteolytic change is visible around the calcar. As the original bearing was ceramic-on-ceramic, this finding cannot reasonably be attributed to polyethylene wear debris. The appearance is more compatible with progressive proximal bone loss and an adverse local host response, which may have contributed to loss of biological fixation over time. The retrieved stem also appears to show limited residual bone attachment. The absence of an immediate postoperative radiograph prevents assessment of the original stem-to-canal fit. If the stem had been undersized from the outset, earlier thigh pain or impaired fixation might have been expected; however, the patient`s clinical course during the first postoperative years is unknown. It is therefore not possible to determine whether the current appearance reflects initial undersizing or progressive bone rarefaction around an initially satisfactory implant. The cause remains undetermined, and there is no evidence of device malfunction. R&D Analysis From the images and the information reported it is visible the explanted stem covered with patient blood. Looking at the stem body an opaque white film is visible on approximately proximal half of 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. Batch review performed on 14 July 2026 Lot 152984: (b)(4) items manufactured and released on 06-Oct-2015. Expiration date: 2020-Sep-02. No anomalies found related to the problem. To date, all items of the same lot have been sold with one similar reported event during the period of review. Root cause:Based on the available information, no definitive root cause for the stem loosening could be established. The radiographic and clinical findings suggest that progressive proximal bone loss and a gradual loss of biological fixation may have contributed to the event; however, no device malfunction or potentially related manufacturing issue was identified.