Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Ambulation Difficulties (2544); Swelling/ Edema (4577)
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Event Date 05/08/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical devices: item #: unknown, unknown tibal base lot #: unknown; item #: unknown, unknown tibal insert lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001825034 - 2021 - 01034, 0001825034 - 2021 - 01035.
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Event Description
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It was reported by patient's legal counsel that the patient underwent a right ankle procedure.The initial pmi device requested was for the left side and was not usable for this procedure.Spacers were placed and a right pmi device was ordered mirrored from the left ankle scans.Initial implantation completed a month later.Legal counsel is reporting patient has filed an allegation claiming pain, stiffness, ambulatory issues and scarring.No revision has been reported at this time.No additional information is available at this time.
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Manufacturer Narrative
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(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies related to the event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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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No further event information available at the time of this report.
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Manufacturer Narrative
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(b)(4).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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Initial right ankle procedure with a patient matched talus implant.The patient is experiencing ongoing pain, swelling, stiffness, and limited range of motion in the foot and ankle.The patient uses an orthotic brace for ambulation.Infection was ruled out, and the ankle appears stable on x-ray; however, the patient is considering more invasive surgery to mitigate the pain she states is intolerable.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Reassessment of the additional information does not change the previous investigation findings.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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