Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Muscular Rigidity (1968); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)
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Event Date 08/18/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical devices: item 90597003010 lot 64198343; item 00597206532 lot 64143810; item 00598603701 lot 63980326.Foreign (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00295, 0002648920-2021-00018.
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Event Description
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It was reported that approximately 1 year post a left tka, the patient underwent manipulation under anesthesia due to stiffness and difficulty ambulating.Attempts have been made and no further information has been provided.
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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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(b)(4).This follow-up report is being submitted to relay additional information.This complaint was not confirmed as official medical records were not provided.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Joint assist records were provided and reviewed by a health care professional.Review found at 1 year visit patient had difficulty ambulating and stiffness.Patient had mua and was resolved.Further medical records were not provided.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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Search Alerts/Recalls
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