Catalog Number 161470 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Arthritis (1723); Insufficient Information (4580)
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Event Date 07/24/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10.Item#:159554 ;lot#:65677138 ;item name: oxf anat brg lt lg size 3 pma; item#:154775 ;lot#:591490 ;item name:oxf uni tib tray sz f lm pma; item#:98-b002-006-01 ;lot#:unknown ;item name:oxf uni fm/cm tb/uni ; multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00281 , 3002806535 - 2023 - 00283.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Event Description
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It was reported that the patient underwent revision surgery due to unknown reasons.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Manufacturer Narrative
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(b)(4).Additional information was received indicating that a revision surgery was needed due to lateral progression of the patient's arthritis.Upon review of this information, it is now considered that the oxford femoral component within this complaint has not caused or contributed to the reported event.Hence this report will be voided.Given the above information this medwatch will be voided.
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Event Description
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Additional information was received indicating that a revision surgery was needed due to lateral progression of the patient's arthritis.Upon review of this information, it is now considered that the oxford femoral component within this complaint has not caused or contributed to the reported event.Hence this report will be voided.
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Search Alerts/Recalls
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