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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
Unspecified Infection (1930); Pain (1994); Tissue Damage (2104); Blood Loss (2597)
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Event Date 09/10/2018 |
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 report: 0001825034-2020-02903, 0001825034-2020-02904.Concomitant medical products: biomet cc i-beam tray 71mm, item# 141223, lot# j6061624.Van ps open intl fem-lt 70 , item# 183132, lot# j3880066.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 a patient underwent a phase one revision approximately one year and seven weeks post implantation due to infection.An arthroscopy was performed four months earlier.The tibial component was found to be loose as a consequence of the infection.All components were removed and antibiotic cement spacers were placed.A picc line was placed and the patient received iv antibiotics.Three months and eleven days later the patient was re-implanted with a new left total knee arthroplasty.There is no additional information at this time.
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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 is being submitted to relay additional information.The reported event of deep infection greater than ninety days occurred post implantation.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.Noted events of tibial component loosening, blood loss and postop anemia are all secondary to the infection, as noted by the surgeon in the medical records.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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