This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h2, h6, h10 the reported event of deep infection of <90 day duration occurred post implantation.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.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.This patient has a history of leukopenia which can inhibit the body's ability to fight infection due to low white blood cell count.As no product information was provided, validation of sterile certifications can not be performed, therefore the reported device can not be excluded as a possible source of the reported infection.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: two weeks post-op appointment noted small amount of clear drainage from the bottom of the incision.Redness around the incision.Began a course of antibiotics.Patient continued to experience drainage and had small opening near the bottom of the incision seven days later.Surgeon discussed possibly washing out the seroma and possibility of having a drain placed.Three weeks post-op, surgeon noted incision continues to ooze.Surgeon thinks possible reaction to the vicryl sutures.Three months post-op surgeon noted the shoulder was draining and a small blister like area opened up.Cultures grew enterobacter.Continued antibiotics.At the end of the month, the incision area opened up subcutaneously.Five months post-op patient had an i&d and washout.In (b)(6) 2017 surgeon felt wound was completely healed.In (b)(6) 2018, patient called to say his shoulder was infected.Shoulder aspirated and cultures sent.Started on antibiotics (amoxicillin and bactrim).Cultures showed enterobacter cloacal.Added cipro when amoxicillin finished.In (b)(6) 2018, patient called stating the infection was back again.The surgeon observed a 3cm swelling over mid-incision and diagnosed it as an apparent abscess.Abscess drained and cultures sent.Patient referred to infectious disease specialist.Continued cipro/bactim regime that was previously ordered.Patient underwent surgery for implant removal and abx spacer placement.In (b)(6) 2018, pt complained of bleeding which was resolved; however, now has leg pain.Therefore, patient was started on gabapentin.On (b)(6) 2018, patient presented to er with worsening fatigue, chronic leg pain, fever, chills, decreased appetite, and sweating.Patient became lethargic with difficulty walking and slurred speech.Patient diagnosed with leukopenia, and suffering redness at the bottom of the incision.Patient ordered to continue receiving i.V.Antibiotics.On (b)(6) 2018, patient presented to er again, complaining of weakness, fever, shaking, left foot drop, mild erythema to the left should wound, disoriented and not making sense.Patient had picc line d/c and placement of a central line.Patient was diagnosed with septic shock.From (b)(6) 2019 ¿ (b)(6) 2019, completed i.V.Antibiotics.Still complaining of leg pain and foot drop.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided for the locking screw products.A definitive root cause cannot be determined.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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