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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Swelling/ Edema (4577)
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Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).G2: foreign - canada.D10: medical product - zimmer biomet screw catalog #: unknown lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2024-00103.
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Event Description
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It was reported a patient had a bilateral tmj procedure approximately six years ago.Subsequently, the patient developed pain and swelling and approximately four years ago, underwent a biopsy and revision of a few screws.Attempts have been made and no further information has been provided.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; g3; g6; h1; h2; h3; h6; h11.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.The design of the device was reviewed by the design vendor.Review of the dhr shows that all parts were planned, designed, and manufactured conforming to internal procedures.Planned screw placement was reviewed and it appears that sufficient bony contact and registration for screws to hold the implants in place.With the information provided, no further investigation can be completed.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.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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