Catalog Number 40930 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hypersensitivity/Allergic reaction (1907)
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Event Date 04/07/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical devices: fibula comp lock plate 8h ste cat: 856204008 lot: 489020; 3.5x14mm low pro cort scr ste cat: 851235014 lot: 199400; 3.5x14mm low pro cort scr ste cat: 851235014 lot: 979670; 3.5x10mm cort lock scr ste cat: 856135010 lot: 485430; 3.5x12mm cort lock scr ste cat: 856135012 lot: 486790; 3.5x12mm cort lock scr ste cat: 856135012 lot: 486960; 3.5x14mm cort lock scr ste cat: 856135014 lot: 716290; offset end cap 11x10mm cat: 14-441282 lot: 625640; ti-dble lead cort 5.0x32mm scr cat: 14-405032 lot: 497210; ti-dble lead cort 5.0x34mm scr cat: 14-405034 lot: 656950; ti-dble lead cort 5.0x36mm scr cat: 14-405036 lot: 220160; ti-dble lead cort 5.0x38mm scr cat: 14-405038 lot: 682280; ti-dble lead cort 5.0x42mm scr cat: 14-405042 lot: 483550.Foreign: (b)(6).It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.Product remains implanted.
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Event Description
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It was reported that the patient had an allergic reaction to the implants.It was indicated that the patient will be revised.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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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No further event information available at the time of this report.
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Search Alerts/Recalls
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