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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
Cellulitis (1768); Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)
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Event Date 04/23/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a right knee arthroplasty revision to address severe pain, swelling, instability, difficulty performing daily activities and difficulty straightening the right leg approximately four (4) months post-operatively, despite home exercises and therapy.Initial operative notes noted no intraoperative complications, however, the patient was additionally treated intravenously five (5) days post-operatively for cellulitis.Revision operative notes noted the patient had obvious valgus alignment of the tibial component, however, all components were found to be well-fixed and no wear or damage was seen with the patella.The patient's range of motion at the end of the procedure was 0-125 degrees.Attempts have been made, however, no additional information is available.
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Manufacturer Narrative
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(b)(4).D10 - concomitant devices - persona cruciate retaining cemented narrow femoral component right size 6 catalog #: 42502006002 lot #: 64468330, persona cemented stemmed tibial component right size d catalog #: 42532006702 lot #: 64374539, persona ultracongruent articular surface right 13mm catalog #: 42522200413 lot #: 63551523, persona stem extension tapered cemented 14 mm diameter +30 mm length catalog #: 42557000114 lot #: 64529728 the complainant has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 3007963827-2023-00161, 3007963827-2023-00162, 0001822565-2020-00460, 0002648920-2023-00121 and 0001822565-2023-01623.This report was previously submitted erroneously on feb 6, 2020 and jun 10, 2020 under manufacturing report number 0001822565-2020-00461.H3 other text : investigation incomplete.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Medical records provided and previously reported confirm the reported event.The device history records were reviewed and no discrepancies were identified.The reported infection was found to not be related to the device, however, a definitive root cause could not be determined with the information provided.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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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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