This follow-up report is being submitted to relay corrected and additional information.Additional: h2, h6.Correction: b4, g4, g7, h10.Event summary: it was reported that the patient was implanted in the right hip with a biolox head on (b)(6) 2018 and revised on the (b)(6) 2019 due to pain and severe squeaking.The pain and severe squeaking have been noted as starting to occur not long after initial surgery.Review of received data patient call notes received dated (b)(6) 2019.It rules out the case of a trauma incident.Testing of a potential metal allergy and potential infection have been ruled out negative.Extract from clinic notes received through the sales rep.List of implanted products in primary and revision surgery received.Event of pain and squeaking confirmed in notes.Medical records were not provided.Devices analysis no product was returned to zimmer biomet for in-depth analysis.Review of product documentation this device is intended for treatment.The compatibility check was performed from (b)(4) and showed that the product combination was approved by zimmer biomet.Dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Raw material certificate reviewed on: (b)(6) 2020.The review showed that the specifications were met.The investigation results did not identify a non-conformance or a complaint out of box (coob).Conclusion summary it was reported that the patient was implanted in the right hip with a biolox head on the (b)(6) 2018 and revised on the (b)(6) 2019 due to pain and severe squeaking.The pain and severe squeaking have been noted as starting to occur not long after initial surgery.Neither devices nor photos of the explanted implant were received; therefore, the condition of the components are unknown.Medical records were not provided; patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.As noted by the patient through e-mail communication, "the reason for the noise is that it looked like the stem extension was rubbing against the outer edge of the cup".This could possibly indicate notching of the femoral stem neck.However, with neither x-rays nor explants at hand this cannot be evaluated.The reason for the squeaking could be multifactorial, with contributing factors possibly coming from the patient, the implant or the surgical procedure.The pain sustained by the patient cannot be related to a single specific failure mode.Therefore, based on the available information, we were not able to identify an exact root cause.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
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