DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE SECTOR II CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
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Catalog Number 121722052 |
Device Problems
Device Dislodged or Dislocated (2923); Separation Problem (4043)
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Patient Problem
Joint Disorder (2373)
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Event Date 07/18/2018 |
Event Type
Injury
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Manufacturer Narrative
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(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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During revision hip surgery for poly wear/dissociation it was discovered that the liner had dissociated from the cup.The primary surgery was done in 2010, but the femur was revised after a periprosthetic fracture soon after the initial surgery.During the second revision ((b)(6) 2018) it was noted that the stem subsided and there was a lot of laxity in the joint.The cup was revised, a +4/10 degree liner was implanted, and longer heads were added on the femoral side to improve joint tensioning.Patient consequence? no.Action taken for procedure:revised to a new cup and liner.Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.
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Manufacturer Narrative
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Product complaint # :(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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Manufacturer Narrative
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Product complaint #: (b)(4).Investigation summary: examination of the acetabular cup does find evidence to support the reported disassociation event.Product error / contribution to the event is not identified.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.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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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint #: (b)(4).Investigation summary: examination of the acetabular cup does find evidence to support the reported disassociation event.Product error / contribution to the event is not identified.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: 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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