Model Number N/A |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Joint Dislocation (2374); Impaired Healing (2378)
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Event Date 10/31/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: medical product: cer bioloxd option hd 36mm, catalog #: 650-1057, lot #: 2958840, medical product: arcos 15x175mm brch body std, catalog #: 11-303015, lot #: 316650, medical product: arcos con sz a hi 60mm, catalog #: 11-301311, lot #: 869550.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00107.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 the patient underwent initial hip surgery.Subsequently, a revision was performed due to dislocation and delayed healing.
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Event Description
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It was reported that the patient underwent initial hip surgery.Subsequently, a revision was performed due to dislocation and delayed healing.
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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: 3002806535-2020-00107-1.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.The sterilisation certificates were reviewed and confirmed that the product is sterilised within the specification range.A review of the complaint database over the last 3 years has found 1 similar complaint for this item code 650-1057 and 2 similar complaints found for the item 650-1067.There were no trends identified from the complaint history review.No same lot numbers, no same hospitals and there are no trends in the cause.Without the opportunity to examine the complaint product, the root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Product not returned.
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Search Alerts/Recalls
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