Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)
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Event Date 04/17/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Date of birth: b)(6).Concomitant medical products: item # 42558000601, lot # 63458359.Item # 42518200809, lot # 63425060.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-03379, 0001822565-2019-03381.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 primary left partial knee was performed and subsequently at the one-year clinical visit the patient reports moderate pain, decline in activity of daily living, decline in ambulating and dissatisfied.No revision has been scheduled at this time.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The following section was corrected: no medical intervention has been reported to date.Foreign- belgium.Reported event was unable to be confirmed due to limited information received from the customer.Device remains implanted, therefore no visual inspection can be performed.Device history record (dhr) was reviewed and no discrepancies were found.Medical records were provided and reviewed by a health care professional.The medical records identified: moderate pain, difficulty ambulating for periods of time greater than 30 minutes, mild medial joint line pain, dissatisfied with end results, and patient is anxious and depressed.A definitive root cause cannot 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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Event Description
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No further event information available at the time of this report.
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Event Description
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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 1825034.
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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 1825034.
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Search Alerts/Recalls
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