Model Number 1035-45-000 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/04/2022 |
Event Type
malfunction
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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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Event Description
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It was reported that size 45mm bipolar head and 28+8.5mm head would not seat all the way when implant was assembled.The poly portion of the head appears too small and can disassociate poly from head by pressing with fingers.Surgeon did not feel confident implanting the assembled implant so a second implant was opened and didn¿t not have the same issue as the first implant opened and assembled.Doe: (b)(6) 2022.Affected side :left side.
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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 : visual analysis of the returned sample 103545000/self cent hip 45x28 gry exhibited that metal head was stuck into poly bearing insert so no further analysis on the part could be performed.The reported allegation was not be to be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : a manufacturing record evaluation was performed for the finished device (103545000/jt9931 product and lot numbers, and no non-conformances were identified.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : visual analysis of the returned sample 103545000/self cent hip 45x28 gry exhibited that metal head was stuck into poly bearing insert.It was not possible to disassemble devices, a disassociation among femoral head and liner seems hardly possible.No further analysis on the part could be performed.The reported allegation was not able to be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : a manufacturing record evaluation was performed for the finished device (103545000/jt9931 product and lot numbers, and no non-conformances were identified.
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Search Alerts/Recalls
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