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Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Hematoma (1884); Thrombosis (2100)
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Event Date 05/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: tibia cemented; p/n: 42532007902, l/n: 64019716; femur cemented; p/n: 42500606802, l/n: 63740573; articular surface fixed; p/n: 42522601012, l/n: 63512474; stem extension cemented; p/n: 42557000114, l/n: 63512474; all-poly patella cemented; p/n: 42540200038, l/n: 63761686.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to it 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 reports: 0001822565 - 2018 - 06229, 3007963827 - 2018 - 00194, 0001822565 - 2018 - 06230.Remains implanted.
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Event Description
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It was reported a patient underwent initial total right knee arthroplasty two months post-implantation.Subsequently, the patient experience's a blood clot.No additional patient consequences were reported.
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Manufacturer Narrative
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This follow-up report is being submitted to relay updated and additional information.Updated: a5, b4, b5, d11, g4, g7 additional: h1, h2, h6, h10 d11 medical products: tibia cemented; p/n: 42532007902, l/n: 64019716; femur cemented; p/n: 42500606802, l/n: 63740573; articular surface fixed; p/n: 42522601012, l/n: 63512474; stem extension cemented; p/n: 42557000114, l/n: 63927891; all-poly patella cemented; p/n: 42540200038, l/n: 63761686; hex head screw; p/n: 00590103533, l/n: 63883463.Complaint sample was evaluated via medical records and the reported event was confirmed.Medical records were provided and reviewed by a health care professional.Review of the available records identified no complications during the primary surgery.Office notes identified the patient developed a postoperative blood clot within 2 months of the right tka.Dhr was reviewed and no discrepancies were found.Root cause was unable to 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 03350, 0001822565 - 2019 - 03351.
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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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Search Alerts/Recalls
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