Model Number 01.12.032 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
Joint Disorder (2373)
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Event Date 01/08/2020 |
Event Type
Injury
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Manufacturer Narrative
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Batch review performed on 23 december 2019: lot 152982: (b)(4) items manufactured and released on 26-oct-2015.Expiration date: 2020-10-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medacta medical affairs manager: hip revision surgery performed 1 year after cementless total hip arthroplasy in a 69 year old woman.No information concerning patient health status, bone quality or presence of comorbidities is available.In the radiographic images provided, radiolucent lines around the stem and signs of stress shielding are visible.Aseptic loosening is a possible literature described adverse event after cementless total hip arthroplasty and causes are often unknown.In this case external conditions such as early subclinical traumatic events or systemic conditions may have affected stem osseointegration but this cannot be confirmed on the basis of available information.The reason of this event cannot be determined.
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Event Description
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Revision surgery performed almost 1 year and 2 months after primary following stem loosening.More details will follow once the surgery will be completed.
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Event Description
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Revision surgery performed almost 1 year and 2 months after primary following stem loosening.Stem, head and liner were revised.The surgery was completed successfully.
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Manufacturer Narrative
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Event description has been updated.Stem received on 04.02.2020: visual inspection performed by medacta r&d deprtement : the visual inspection shows intact ha layer from cetral to proximal part of the femoral stem.There are present signs of extraction on head, liner, and neck.
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Search Alerts/Recalls
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