Catalog Number 73-2416 |
Device Problems
Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
Failure of Implant (1924)
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Event Date 02/22/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00119.0001032347-2021-00120.0001032347-2021-00121.0001032347-2021-00123.0001032347-2021-00311.0001032347-2021-00312.0001032347-2021-00313.0001032347-2021-00314.0001032347-2021-00315.0001032347-2021-00124.0001032347-2021-00316.0001032347-2021-00317.0001032347-2021-00318.Item# 73-2634; lot# unk.Item# unk wire; lot# unk.Item# unk wire; lot# unk.Item# 73-2416; lot# unk.Item# 73-2416; lot# unk.Item# 73-2416; lot# unk.Item# 73-2416; lot# unk.Item# 73-2416; lot# unk.Item# 73-2416; lot# unk.Item# 73-2418; lot# unk.Item# 73-2418; lot# unk.Item# 73-2418; lot# unk.Item# 73-2418; lot# unk.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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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It was reported that the patient was originally implanted approximately three (3) months ago.Subsequently, the patient was revised three (3) days post-implantation due to instability.During the revision, it was found the wires were fractured and the plate was loose.The screws were removed and reused with the new implant.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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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot be determined.If any further information 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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Search Alerts/Recalls
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