Model Number N/A |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Cellulitis (1768); Failure of Implant (1924); Sepsis (2067)
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Event Date 11/05/2019 |
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: 0001822565-2022-02775, 0001822565-2022-02776, and 0001822565-2022-02777.Implant date: unknown date in 2017.Medical devices: articular surface size cd 10 mm height catalog#: 00596203010 lot#: ni.Stemmed tibial component precoat size 3 catalog#: 00598003701 lot#: ni.Palacos r 1x40 single catalog#: 00111214001 lot#: ni.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that patient underwent an initial knee arthroplasty.Subsequently, patient reported developing sepsis and cellulitis and was revised for those reasons as well as implant loosening.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.D10 medical devices: articular surface size cd 10 mm height catalog#: 00596203010 lot#: ni.Stemmed tibial component precoat size 3 catalog#: 00598003701 lot#: ni.Palacos r 1x40 single catalog#: 00111214001 lot#: ni.Taper stem plug catalog#: 00596009900 lot#: ni.
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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.Proposed component code: mechanical (g04) - femur.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 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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