Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Numbness (2415)
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Event Date 12/12/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant devices: persona partial knee cemented femoral component size 5 right medial catalog #: 42558000502 lot #: 63856205, persona partial articular surface right medial size f 9mm catalog #: 42528200609 lot #: 63449781.Foreign report source: (b)(6).The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.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: 3007963827-2020-00216.0001825034-2020-03456.
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Event Description
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It is reported that a patient experienced significant discomfort and numbness in the medial aspect of the knee nineteen (19) months following right knee arthroplasty.A the patient was advised to continue reducing weight and no medical intervention was performed.Attempts have been made for additional information, however, no additional information is available at this time.
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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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Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).A corrected report has been filed: (b)(4).
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Search Alerts/Recalls
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