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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Burning Sensation (2146); Numbness (2415); Ambulation Difficulties (2544)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant products: catalog#: 103534 ti low profile screw 6.5x35mm ia6.5x35mm lot#: 624060.Catalog#: 103532 bm acet lp dome scw ti s/tap d ia6.5x25mm lot#: 120880.Catalog#: 135300 acetabular apex plug lot#: 033870.Catalog#: 11-363662 36mm cocr mod hd std lot#: 351930.Catalog#: 105994 rnglc lnr 26mm hwall 24 lot#: 464560.Catalog#: 51-104110 tprlc 133 t1 pps ho 11x142mm 2mm t1 lot#: 3727019.The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.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: 0001825034-2021-01594, 0001825034-2021-01601, 0001825034-2021-01602, 0001825034-2021-01603, 0001825034-2021-01605, 0001825034-2021-01608.
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Event Description
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It was reported the patient is experiencing a feeling like fire is running down the leg and hip, numbness, pain, feels like a tennis ball is in the butt cheek, the patient cannot ride in a vehicle for long periods, and the patient has difficulty lifting his leg approximately 4 years and 9 months post implantation.Attempts have been made and additional information on the reported event is unavailable at this time.
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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.D10: catalog#: 103534, ti low profile screw 6.5x35mm ia6.5x35mm, lot#: 642060.Catalog#: 103532, bm acet lp dome scw ti s/tap d ia6.5x25mm, lot#: 120880.Catalog#: 135300, acetabular apex plug, lot#: 033870.Catalog#: 11-363662, 36mm cocr mod hd std lot#: 351930.Catalog#: xl-105994, arcomxl 36mm rlc lnr mrom, sz24, lot#: 464560.Catalog#: 51-104110, tprlc 133 t1 pps ho 11x142mm 2mm t1, lot#: 3727019.The following sections were updated/corrected: corrected: d4 (lot number).
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g3, g6, h2, h3, h6, h10 reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported 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 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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