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Model Number N/A |
Device Problem
Material Erosion (1214)
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Patient Problems
Pain (1994); Discomfort (2330); Osteolysis (2377); Metal Related Pathology (4530); Swelling/ Edema (4577)
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Event Date 11/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2024 - 00304 0001825034 - 2024 - 00306 0001825034 - 2024 - 00307 the customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that approximately thirteen years post-implantation, the patient underwent a revision due to pain, swelling, stiffness, osteolysis, pseudotumor, and elevated metal ions.During the procedure, a large amount of metal stained fluid was seen.A moderate periarticular pseudotumor was debrided.The head was exchanged with a polyethylene articular surface without complications.Attempts have been made and no further information has been provided.
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Event Description
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No further information is available at the time of this report.
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Manufacturer Narrative
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(b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Complaint confirmed based on the review of provided medical records.Part and lot identification are necessary for review of device history records, neither were provided.Medical records identified the following: failure secondary to metallosis.Posterior approach with a large metal stained fluid evacuated.Moderate periarticular pseudotumor debrided.Stem and cup well fixed and remained implanted.X-ray: no loosening or failure, noted osteolysis in greater trochanter with no progression.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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