Model Number N/A |
Device Problem
Mechanical Problem (1384)
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Patient Problem
Loss of Range of Motion (2032)
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Event Date 12/30/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Concomitant medical products: medical product: oxf twin-peg cmntd fem sm pma, catalog #: 161468, lot #: 400140.Medical product: oxf anat brg lt sm size 3 pma, catalog #: 159540, lot #: 562700.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00025, 3002806535-2021-00026.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 an initial left unilateral tka was performed on (b)(6) 2020.Subsequently, the patient had a manipulation under anaesthesia (mua) on (b)(6) 2020 due to stiffness and limited mobility.
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Manufacturer Narrative
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Cmp-(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a1, a2, b4, b5, g4, g7, h1, h2, h10.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00025-1, 3002806535-2021-00026-1.Additional information received: -operative notes received.-patient information received: patient name: (b)(6).Patient age: 43 years.The investigation is in process.Once the investigation has been completed, a supplemental mdr will be submitted.
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Event Description
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It was reported that an initial left unilateral tka was performed on (b)(6) 2020.Subsequently, the patient had a manipulation under anaesthesia (mua) on (b)(6) 2020 due to stiffness and limited mobility.
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Manufacturer Narrative
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(b)(4).This final report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00025-2, 3002806535-2021-00026-2.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, we have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found 2 complaints reported with the item 154718,3 complaints reported with the item 161468 and 3 complaints reported with the item 159540 including initiating complaint.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.
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Event Description
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It was reported that an initial left unilateral tka was performed on (b)(6) 2020.Subsequently, the patient had a manipulation under anaesthesia (mua) on (b)(6) 2020 due to stiffness and limited mobility.
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Search Alerts/Recalls
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