MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5; HIP CEMENTLESS STEM
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Model Number 01.12.025 |
Device Problem
Migration (4003)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/31/2023 |
Event Type
Injury
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Event Description
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On (b)(6) 2022 the patient had a primary hip surgery.After the primary, the patient suffered a trauma resulting in a bone femoral fracture, which was not treated surgically.Presently, on (b)(6) 2023, the patient was revised because of the subsided stem.The surgery was completed successfully.
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Manufacturer Narrative
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Batch review performed on 03-feb-2023.Lot 2005138: (b)(4) manufactured and released on 14-aug-2020.Expiration date: 2025-08-05.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported case during the period of the review.Clinical evaluation performed by medacta medical affairs manager: revision 10 months after primary total hip surgery due to a subsided stem consequent to a femoral fracture.After the primary, the patient suffered a trauma resulting in a femoral fracture, which was not treated surgically.From the radiographic image, the subsided stem is visible.It is probable that due to the (early) trauma the stem subsided.There is no reason to suspect a faulty device.
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Manufacturer Narrative
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Visual inspection performed by r&d manager: looking at the stem body an opaque white film is visible on approximately whole 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, even if the fracture could be a possible cause.
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