ZIMMER BIOMET, INC. PARTIAL ARTICULAR SURFACE RIGHT MEDIAL SIZE E 8 MM THICKNESS; PROSTHESIS, KNEE
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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
Wound Dehiscence (1154); Abscess (1690)
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Event Date 05/23/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Dob: (b)(6).Concomitant medical products: 42558000402, partial femur cemented, lot # 63532896, 42538000502, partial tibia cemented, lot # 63881381.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 04427, 3007963827 - 2019 - 00294.
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Event Description
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It was reported that approximately 6 weeks post implantation, the patient was treated for wound dehiscence and stitch abscess.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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Event occurred in the (b)(6).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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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 update/corrected updated: b4, b5, g4, g7, h2, h3, h6.The reported event was able to be confirmed by review of the provided clinic notes.Office notes state that patient experienced a small amount of weeping from the surgical wound and a stitch abscess approximately 6 weeks post implantation.Patient was treated with antibiotics and infection resolved within 1 week.Review of the device history records identified no deviations or anomalies during manufacturing.The root cause for the reported issue is related to the procedure and not abnormal.There is no failure detected within the device.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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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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