Model Number 1172-25-000 |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Inadequate Osseointegration (2646); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).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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The primary surgery was performed on (b)(6) 2004 via tha by using the cup (p/n: 960013000), the liner (p/n: 960019000), the stem (p/n: 900531210) with the sleeve (p/n: 521465), the head (p/n: 152190051).It was reported that the revision surgery was scheduled to be performed on (b)(6) 2020 by replacing the cup due to loosening acetabular side.
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Manufacturer Narrative
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Product complaint # (b)(4).Initial contact is a health professional, not a lawyer.
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Manufacturer Narrative
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Product complaint # (b)(4).H6 patient code: no code available (3191) used to capture device revision or replacement.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. .
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Event Description
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Additional information received indicating: the patient has had hip osteotomy in the past, the primary surgery was performed on (b)(6) 2004 via tha for the right hip joint.Since the acetabular wear was remarkable, the revision surgery was performed as scheduled.All implants on the acetabular side were explanted, allograft, artificial bone and metal mesh were transplanted, a cemented cup was fixed.The stem was retained.The poly liner was worn out enough to be visually recognized by x-ray.
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Manufacturer Narrative
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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 heen able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Device history lot : null.Device history batch : null.Device history review : null.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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Search Alerts/Recalls
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