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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
Fatigue (1849); Fever (1858); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Chills (2191); Malaise (2359); Ambulation Difficulties (2544); Swelling/ Edema (4577)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02576, 0002648920-2023-00223, and 0002648920-2023-00224.D10 medical devices: articular surface size ef 10 mm height catalog#: 00596204010 lot#: 61805332; stemmed tibial component precoat size 6 catalog#: 00598004702 lot#: 61819673; all poly patella standard cemented size 35 mm diameter 9.0 mm thickness catalog#: 00597206535 lot#: 61852905.G2 foreign source: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it 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 the patient underwent an initial left knee arthroplasty.Subsequently, the patient was evaluated approximately twelve years post-implantation due to knee pain, inability to bear weight, swelling, warmth, and decreased range of motion associated with fevers, chills, poor appetite, and fatigue.Radiograph imaging noted joint effusions.The plan determined was for hospital admission, pain medication, and right knee aspiration.No further details or results are available at this time.
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Event Description
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No additional information.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.H6: suggested component code: mechanical (g04) - femur.The reported event was confirmed via review of the provided medical records.No product was returned, or pictures provided.The provided medical records were reviewed by a healthcare professional and identified knee pain, inability to bear weight, fevers and rigors, poor appetite and fatigue, swollen knees with warmth, decreased range of motion and joint effusions.No history of gout or systemic inflammatory conditions identified.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause could not 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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Search Alerts/Recalls
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