Catalog Number UNKNOWN |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)
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Event Type
Injury
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Event Description
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It was reported that a patient presented with pain, swelling, and limited rom (reduced walking ability) 5 months post-implantation of a tm ankle.The surgeon suspects implant loosening.The implant has yet to be removed from the patient.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).D10: unk tm ankle talus component; unk tm ankle highly crosslinked poly.G2: foreign- sweden.Customer 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 event, please see associated reports: 0001822565 - 2023 - 03343, 0001822565 - 2023 - 03345.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the part and lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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 is available at the time of this report.
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Search Alerts/Recalls
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