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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Item 42540000041 lot 64775343, item 42530008302 lot 64696483, item 42522100910 lot 64453814.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the location of the product is unknown.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: 0002648920-2021-00079, 0001822565-2021-01018, 3007963827-2021-00083.
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Event Description
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It was reported that the patient had an initial knee arthroplasty and subsequently was revised due to infection on an unknown date.Attempts have been made and no additional 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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Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided, as 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.
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Search Alerts/Recalls
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