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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bacterial Infection (1735)
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Event Date 01/25/2019 |
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: 0001822565-2019-00730, 0001822565-2019-00731, 0001822565-2019-00732, 0001822565-2019-00733, 0001822565-2019-00734, and 0001822565-2019-00735.Concomitant medical products: distal femoral xt component size b right catalog#: 00585004202 lot#: ni, segment with male/female taper 30 mm length catalog#: 00585004603 lot#: ni, articular surface with segmental hinge post size b 12 mm height catalog#: 00585002012 lot#: ni, tibial component precoat size 4 catalog#: 00588000400 lot#: ni, stem extension straight 18mm dia x 100mm length catalog#: 00598801018 lot#: ni.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the hospital would not release the devices.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 right knee arthroplasty.Subsequently, patient underwent irrigation, debridement, and replacement of components due to suspected infection and tibial loosening.
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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.The product could not be evaluated and the reported event was not confirmed.The device history records could not be reviewed as the lot number associated with the reported event is unknown.Single-use, sterilized devices manufactured or distributed by zimmer are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is highly unlikely that the specified device caused any patient infection.However, a definitive root cause could not 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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Search Alerts/Recalls
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