Zimmer biomet complaint (b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00283, 0001032347-2021-00284, 0001032347-2021-00285, 0001032347-2021-00286, 0001032347-2021-00287, 0001032347-2021-00288, 0001032347-2021-00289, 0001032347-2021-00290, 0001032347-2021-00291, 0001032347-2021-00292, 0001032347-2021-00293, 0001032347-2021-00294, 0001032347-2021-00296, 0001032347-2021-00297, 0001032347-2021-00298, 0001032347-2021-00299, 0001032347-2021-00300.Medical products: 2.0 lactosorb system l-plate - left - regular, part# 915-2102, lot# 847100.2.0 lactosorb system l-plate - left - regular, part# 915-2102, lot# 847100.2.0 lactosorb system 2.0 x 7 mm lactosorb screw, part# 915-2301, lot# 849260.2.0 lactosorb system 2.0 x 7 mm lactosorb screw, part# 915-2301, lot# 849260.2.0 lactosorb system 2.0 x 7 mm lactosorb screw, part# 915-2301, lot# 849260.2.0 lactosorb system 2.0 x 7 mm lactosorb screw, part# 915-2301, lot# 849260.2.0 lactosorb system 2.0 x 7 mm lactosorb screw, part# 915-2301, lot# 849260.2.0 lactosorb system 2.0 x 7 mm lactosorb screw, part# 915-2301, lot# 849260.2.0 lactosorb system 2.0 x 7 mm lactosorb screw, part# 915-2301, lot# 849260.2.0 lactosorb system 2.0 x 7 mm lactosorb screw, part# 915-2301, lot# 849260.2.0 lactosorb system 2.0 x 7 mm lactosorb screw, part# 915-2301, lot# 849280.2.0 lactosorb system 2.0 x 7 mm lactosorb screw, part# 915-2301, lot# 849280.2.0 lactosorb system 2.0 x 7 mm lactosorb screw, part# 915-2301, lot# 849280.2.0 lactosorb system 2.0 x 7 mm lactosorb screw, part# 915-2301, lot# 850040.2.0 lactosorb system 2.0 x 7 mm lactosorb screw, part# 915-2301, lot# 850040.2.0 lactosorb system 2.0 x 7 mm lactosorb screw, part# 915-2301, lot# 850040.2.0 lactosorb system 2.0 x 7 mm lactosorb screw, part# 915-2301, lot# 850040.Report source: (b)(6).
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It was reported that approximately 10 months postop, the patient presented with signs of infection during the resorption stage of the implant.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.Upon reassessment of the reported event based on additional information.This product did not cause or contribute to the reported event.This initial report submitted needs to be voided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.
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