ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD LEFT SIZE 10; PROSTHESIS, KNEE
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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Pain (1994); Swelling (2091); Skin Inflammation (2443); No Code Available (3191)
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Event Date 06/05/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: item # 42532007901, lot # 64249765.Item # 42511000610, lot # 64235954.Report source: foreign: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2019-00292, 3007963827-2019-00293.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that the patient underwent an initial left knee arthroplasty; subsequently, the patient experienced pain, redness, warmth, swelling and discharge from the wound around the suture line approximately one month post implantation.The wound was cleaned and the patient was prescribed a seven day course of antibiotics.The adverse event has been resolved and no further medical intervention has been reported to date.Attempts have been made, and no further 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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(b)(4).Complaint confirmed with crf report.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Crf report the patient underwent initial left tka.Crf report demonstrated that the patient experienced pain, redness, warmth, swelling and discharge from the wound around the suture line.No failure detected with the devices.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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