This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additional information was received on mar 15, 2021.The manufacturer received x-rays and other source documents for review.Should additional information become available and /or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).
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This follow-up report is being submitted to relay corrected and additional information.Additional: h2, h6 correction: b4, g3, g6, h10.Event description: it was reported that the patient was implanted in the right hip with a revitan stem on an unknown date and underwent revision surgery on (b)(6) 2021 due to implant fracture.Further, it was reported that the patient had initial surgery in 1994 and underwent revision surgery in 2002.However, it remains unknown what devices were revised in 2002.Review of received data: - due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.- x-rays: the following x-ray analysis was performed by a radiologist.Two ap views and a cross table lateral view of the hip and proximal right femur from (b)(6) 2020 were received.There is a fracture of the proximal aspect of the femoral implant with mild angulation.No osseous fracture or dislocation is noted.Multiple cerclage wires are present and intact.Radiolucency is noted along the femoral implant greatest proximally and medially most likely related to the original implant prior to revision.- patient data: c.M., male, born on (b)(6) 1950, 87kg, 178cm.Product evaluation: - no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: - device purpose: this device is intended for treatment.- product compatibility: the compatibility check could not be performed due to missing product identification.- dhr review: review of the device history records could not be performed due to missing product identification.Conclusion: it was reported that the patient was implanted in the right hip with a revitan stem on an unknown date and underwent revision surgery on (b)(6) 2021 due to implant fracture.Further, it was reported that the patient had initial surgery in 1994 and underwent revision surgery in 2002.However, it remains unknown what devices were revised in 2002.Review of the manufacturing records, the complaint history and the product compatibility could not be performed due to unknown product identification.Further, due to the unavailability of the product, a visual examination could not be performed.Based on the evaluation of the x-ray images provided, the reported stem fracture can be confirmed.However, due to the lack of additional medical data and product, we were unable to determine a specific cause for this complaint.Based on the known information, a nonconformity or a "complaint out of box" (coob) was not determined.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
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