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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
Cellulitis (1768); Pain (1994); Loss of Range of Motion (2032); Sepsis (2067)
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Event Date 11/05/2019 |
Event Type
Injury
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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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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02774, 0001822565-2022-02776, and 0001822565-2022-02777.Implant date: unknown date in 2017.Concomitant medical devices: unknown femoral, catalog#: ni, 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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.D10 medical devices:
unknown femoral catalog#: ni 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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Supplemental for implant date and associated products.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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.For the reported infection, it occurred over 90 days post-procedure; therefore, the implanted products are not identified as the source or contributing to the reported infection there were no issues or complications with the revised articular surface as it was reported the revision was due to loosening.No problem was found with the articular surface.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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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, pain, and decreased range of motion.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Updated: a2, a3, a4, b4, b5, g3, g6, h2, h6, and h11.
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Search Alerts/Recalls
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