Model Number 1035-65-000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
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Event Date 09/02/2022 |
Event Type
Injury
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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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Clinical notification received for revision due to infection.Date of implantation: (b)(6) 2013.Date of revision #1: (b)(6) 2013.Date of revision #2: (b)(6) 2015.Date of revision #3: (b)(6) 2021.Date of revision #4: (b)(6) 2021.Date of revision#5: (b)(6) 2022.(left hip).
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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.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Event Description
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Patient underwent removal of temporary antibiotic-loaded spacer with placement of final implants secondary to chronic infection of the left hip.¿devitalized¿ tissue was found due to the previously large fluid collections he experienced.There was also a small 2cm central defect in the acetabulum.The surgeon decided to remove the bipolar construct and replace with another bipolar due to the patient¿s history of recurrent dislocations.The final reclaim stem and bipolar head were placed successfully.The devitalized tissue and central defect were noted to be due to the recurring infection process that has now been cleared.
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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.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 (clinical codes) h6 clinical code: unspecified tissue injury (e2015) is used to capture bone injury and soft tissue injury.
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Search Alerts/Recalls
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