ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) LEFT 11 MM HEIGHT; 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
Arthritis (1723); Unspecified Infection (1930); Osteopenia/ Osteoporosis (2651)
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Event Date 05/11/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: foreign - (b)(6).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 will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2022-00158, 0001822565-2022-01679.
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Event Description
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It was reported that the patient underwent a revision surgery approximately 8 years post implantation due to degenerative arthritis.Attempts have been made and no further information has been provided.
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Event Description
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It was reported that the patient underwent an initial knee arthroplasty due to degenerative arthritis.Approximately 8 years post implantation, the patient was revised due to infection.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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