Concomitant medical products: g7 osseoti 3 hole shell 50mm d 0mm d; item# 110010243; lot# 6833659.Liner neutral 36 mm i.D.Size d for use with g7 acetabular system only; item# 30103604; lot# 64843270.Biolox delta, ceramic femoral head, s, 36/-3.5, taper 12/14; item# 00877503601; lot# 3031183.The manufacturer did not receive x-rays for review.Other source documents were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).
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Additional information which was received on feb 24, 2021.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer received primary op report and 6 patient progress notes for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).
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This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that a study patient underwent an initial right tha on (b)(6) 2020.Subsequently, the patient experienced surgical site wound dehiscence, drainage and was diagnosed with deep infection.The patient had phase 1 device removal, i&d, resection, and antibiotic spacer placement on (b)(6) 2021.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Medical records: following a summary of the received medical records consisting of the clinical report form and progress notes: preoperative contributing factors: osteoarthritis, pain 7/10, difficulty ambulating, right leg short by 2mm.Intra and postop findings: initial right tha with no noted intra or postoperative complications.Progression note from (b)(6) 2020: superficial infection, wound dehiscence, wound drainage, patient reports rash that appeared on chest and surgical site, medical intervention.Progression note from (b)(6) 2020: erythema has improved.Drainage increased over the weekend requiring 2-3 dressing changes daily but this has improved as well.Pain is located along incision and lateral thigh but denies hip joint/ groin pain.She has continued bactrim ds bid.Distal incision erythematous with fibrinous exudate, clear drainage.Erythema and swelling improved.No hip joint pain with active or passive motion of hip but notes discomfort along incision.Progression note from (b)(6) 2020 ¿ right hip pain, aspiration of right hip joint.Progression note from (b)(6) 2021: patient returns for 8-week follow up after right hip replacement with distal wound dehiscence.The patient's pain is 7/10 when standing with oral medications.Pain is located mid quad and adductor.Denies groin pain.She has continued bactrim ds daily.Distal incision almost completely closed with minimal blood, no active drainage.Erythema and swelling improved.No hip joint pain with active or passive motion of hip.Ttp along quadriceps.Pain with resisted knee extension.The patient can flex to 100 degrees at the hip, abduct 20 degrees actively, and ambulates with antalgic gait.Progression note from (b)(6) 2021 ¿ full weight bearing antalgic gait, taking pain medication for operative joint, unable to perform exercises, removed from study (b)(6) 2021.Adverse event (b)(6) 2021 ¿ deep infection, complication of skin involving drainage from surgical wound, right hip i&d, resection and placement of antibiotic spacer on (b)(6) 2021.The primary surgical report from 09 nov 2020 was review with no anomalies noted.Product evaluation: the products were discarded; therefore, a product evaluation could not be performed.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Sterilization certificate: the gamma sterilization specification of the devices certifies the suitability of sterilization.The irradiation certificates of the affected lot numbers have been reviewed and were found to be according to specifications.Conclusion: it was reported that a study patient underwent an initial right tha on (b)(6) 2020.Subsequently, the patient experienced surgical site wound dehiscence, drainage and was diagnosed with deep infection.The patient had phase 1 device removal, i&d, resection, and antibiotic spacer placement on (b)(6) 2021.Based on the medical records provided, the wound dehiscence and the suspected infection can be confirmed.Nevertheless, the reported infection could not be confirmed with certainty due to the lack of laboratory results.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Sterilization 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 hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issue that may have affected the implant safety or effectiveness, the implanted products are not identified as the source or contributing factor to the reported infection.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
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