STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_MDM LINER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
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Catalog Number UNK_SHC |
Device Problems
Material Erosion (1214); Insufficient Information (3190)
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Patient Problem
Injury (2348)
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Event Date 04/25/2020 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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In 2013, the patient underwent tha procedure with mdm and accolade tmzf.Then, the neck of the stem has scraped due to the rear impingement.On (b)(6) 2020, the revision surgery is scheduled.***request***please identify based on your investigation what is line of between the polyethylene and the neck, which is on the necked part of the complaint product.
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Event Description
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In 2013, the patient underwent tha procedure with mdm and accolade tmzf.Then, the neck of the stem has scraped due to the rear impingement.On (b)(6) 2020, the revision surgery is scheduled.Request- please identify based on your investigation what is line of between the polyethylene and the neck, which is on the necked part of the complaint product.
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Manufacturer Narrative
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An event regarding wear involving an unknown mdm liner was reported.The event was confirmed.Method & results: device evaluation and results: the provided photograph shows a recently explanted accolade stem reduced into mdm poly with 1 cm deep notch at base of superior neck approx.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: undated, unlabelled photo of explanted femoral stem reduced into mdm poly with 1 cm deep notch at base of superior neck approx.1 cm proximal to trunnion.Undated, unlabelled x-rays ap pelvis, lateral left hip demonstrating a hybrid left tha, reduced, nominal position with a notch at the stem base visible on the lateral x-ray.No clinical or pmh, no patient demographics, no operative reports, no examination of explanted components, no dated serial x-rays.Implant photo and x-ray confirms impingement defect noted in event description, but insufficient data is presented to create a medical report.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the provided photo of explanted accolade stem reduced into mdm poly with 1 cm deep notch at base of superior neck approx.1 cm proximal to trunnion.Unlabelled x-rays ap pelvis, lateral left hip demonstrating a hybrid left tha, reduced, nominal position with a notch at the stem base visible on the lateral x-ray.Explanted device photo and provided x-rays confirms impingement defect noted in event description.
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Search Alerts/Recalls
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