Catalog Number 103543000 |
Device Problem
Fracture (1260)
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Patient Problem
Insufficient Information (4580)
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Event Date 07/31/2023 |
Event Type
Injury
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Event Description
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Hcp is reporting a revision of a duo-head hip-inlay because of fracture.Doi: may 9, 2023.Doe:(b)(6) 2023.Affected side: unknown.
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Manufacturer Narrative
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Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.
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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.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: hcp is reporting a revision of a duo-head hip-inlay because fracture.The device associated with this report was returned to depuy synthes for evaluation.Visual inspection of the returned sample revealed the polyethylene component of self cent hip 43x28 gry, was fractured.However the investigation was not able to determine a potential cause as, this mode of failure is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use) and anatomical considerations.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.Additionally, some markings on the edge of the liners were found, indicating the poly components were making unintended contact with other surface.The overall complaint was confirmed as the observed condition of the self cent hip 43x28 gry would contribute to the alleged device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed for the finished device 103543000 lot number d22091803, 19 pcs parts were manufactured and no non-conformances/ manufacturing irregularities were identified.1) quantity manufactured: (b)(4).2) date of manufacture: 19-sep-2022.3) any anomalies or deviations identified in dhr: no.4) expiry date: 31-aug-2027.5) ifu reference: ifu-0902-00-701.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : hcp is reporting a revision of a duo-head hip-inlay because fracture.The device associated with this report was returned to depuy synthes for evaluation.Visual inspection of the returned sample revealed the polyethylene component of self cent hip 43x28 gry, was fractured.The fracture surface has high stress low cycle fatigue characteristics and the edge of the poly part of the liner is unnaturally worn down suggesting the neck of the stem was extending beyond its angle, however is not possible to fully determine the cause with the information provided, adding that the time that the implant was in the patient (3 months), it reasonable to confirm that the device endured forces beyond the material load.The investigation was not able to determine a potential cause with the information provided as, this mode of failure might be multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use) and anatomical considerations.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A material evaluation is not needed at the time, based on the type of fracture, the mre performed that was not able to find anything indicative of a device nonconformance during the manufacturing process and that this is an isolated case, no previous reports have been received for the finished device 103543000 lot number d22091803.Additionally, some markings on the edge of the liners were found, indicating the poly components were making unintended contact with other surface.The overall complaint was confirmed as the observed condition of the self cent hip 43x28 gry would contribute to the alleged device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a manufacturing record evaluation was performed for the finished device 103543000 lot number d22091803, (b)(4) pcs parts were manufactured and no non-conformances/ manufacturing irregularities were identified.1) quantity manufactured: (b)(4).2) date of manufacture: 19-sep-2022 3) any anomalies or deviations identified in dhr: no 4) expiry date: 31-aug-2027 5) ifu reference: ifu-0902-00-701.
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Search Alerts/Recalls
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