Model Number 86-7421 |
Device Problems
Fracture (1260); No Apparent Adverse Event (3189)
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Patient Problems
Limb Fracture (4518); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/08/2022 |
Event Type
Injury
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Event Description
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Hcp is reporting a fracture of knee-tep´s femoral sleeve extension right side.Doi:
(b)(6) 2021, dor: (b)(6) 2022.
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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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Additional information received indicated that the accident occurred on (b)(6)2022 (wrong movement in the swimming pool).Adverse consequences: new revision and femoral change to a distal femoral replacement.There is no suspicion of a defect in other components.The bone and the implant were broken.The tapered connection from stem to sleeve was broken (thread on stem part broken).
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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).Mfr# 1818910-2022-19644 is being retracted since it was found to be a duplicate of mrf# 1818910-2022-19221.Mfr# 1818910-2022-19221 will be kept for investigation purposes.
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Search Alerts/Recalls
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