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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Neuropathy (1983)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: foreign: (b)(6).Citation : park, sung j., et al."metallosis after using distal fibular locking plate for lateral malleolar fractures: a retrospective study." orthopaedic surgery, 1 mar.2021, pp.1-7, doi:https://doi.Org/10.1007/s00402-020-03713-y.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the 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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The study reported that 1 patient developed peripheral neuropathy.A journal article was retrieved from archives of orthopaedic and trauma surgery (2021) that reported a retrospective study from the republic of korea that looked at the development of metallosis following orif of fractures.The purpose of the study was to assess metallosis following orif using distal fibular locking plates to treat distal fibular fractures.The study reviewed 69 patients who underwent surgery using locking compression plates to treat lateral malleolar fractures with subsequent hardware removal; of these patients, 38 received a zplp plate (zimmer biomet), 16 received synthes lcp plates, and 15 received je-il arix plates.The surgeries were performed at inha university hospital (korea).Of the zplp recipients, 19 patients had unimalleolar fractures, 7 had bimalleolar fractures, and 12 had trimalleolar fractures; 2 patients were classified as weber type a, 31 were weber type b, and 5 were weber type c.The study population had a mean age of 49.3 years at time of surgery (range 18-70 years).Follow-up was conducted at approximately 4-5 times within the first year postoperatively with a mean length of follow-up for 13.92 months (range 12-31 months).
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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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Search Alerts/Recalls
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