It was reported that the patient received unknown treatment approximately one month following right knee arthroplasty to address an unknown, proximal, surgical site infection.Pre-operative notes noted the patient had psoriatic lesions over the surgical site, however, operative notes from (b)(6) 2020 noted no intra-operative complications that would have contributed to the reported event.The patient was additionally given prophylactic antibiotics preventively.No additional information is available.
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(b)(4).Concomitant medical devices: unknown nexgen lcck femoral component size g, catalog #: ni, lot #: ni.Unknown nexgen tibial component size 5, catalog #: ni, lot #: ni.Unknown nexgen lcck articular surface 12mm, catalog #: ni, lot #: ni.Unknown nexgen tibial stem extension 14mm x 100mm, catalog #: ni, lot #: ni.Unknown nexgen distal augment 5mm, catalog #: ni, lot #: ni.Unknown nexgen distal augment 5mm, catalog #: ni, lot #: ni.Unknown nexgen posterior augment 5mm, catalog #: ni, lot #: ni.Unknown nexgen lateral augment 5mm, catalog #: ni, lot #: ni.Report source - foreign: sweden.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the devices remain 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 patient; please see all reports associated with this event: 0001822565-2022-02799, 0001822565-2022-02800, 0001822565-2022-02801, 0001822565-2022-02803, 0001822565-2022-02804, 0001822565-2022-02805, 0001822565-2022-02806, 0001822565-2022-02807.
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This follow-up report is being submitted to relay additional information.H6-component code- suggested code: mechanical (g04) - stem.Superficial infections are considered a procedure related complication as no device has been reported as revised.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.During the investigation process a review of the sterile certifications were not reviewed, as no product part/lot information was provided.All devices manufactured follow acceptable sterilization processes according to published iso/aami/astm & eu guidelines.As the superficial infection was reported and no product information was provided, validation of sterile certifications cannot be performed, therefor the reported event is considered procedure related.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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