Catalog Number 962711000 |
Device Problems
Degraded (1153); Device Dislodged or Dislocated (2923)
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Patient Problems
Foreign Body Reaction (1868); Joint Dislocation (2374)
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Event Date 04/03/2024 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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It was reported that on (b)(6) 2007, the patient underwent the primary surgery via tha with implants in question at another hospital.It was mom (metal on metal) because of frequent dislocation, an x-ray showed that the cup was placed at an abduction angle of about 50 degrees.Therefore, revision surgery was performed on (b)(6) 2024.In that case, the metallosis was confirmed by installation at the mom (metal on metal).The surgeon performed as much implant removal and revision as possible.The cup installation angle was about 50 degrees, which may have caused localized load stress on the metal insert and metal head.This may have led to corrosion between the head and neck.No further information is available.Remark: the cup was registered as polo on (b)(4).
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Product description: 9/10 ultamet 36mm heads +0 product code: 962711000 lot no: 2075913 quantity of manufactured: (b)(4).Date of manufacturing: january 2006.Ant anomalies or deviations identified in dhr: n/a.Expiry date: 24jan2011.Ifu reference: 0902-00-701.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: product description: 9/10 ultamet 36mm heads +0.Product code: 962711000.Lot no: 2075913.Quantity of manufactured: (b)(4).Date of manufacturing: january 2006.Ant anomalies or deviations identified in dhr: n/a.Expiry date: 24jan2011.Ifu reference: 0902-00-701.Device history review: a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities were identified.
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Search Alerts/Recalls
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