DEPUY ORTHOPAEDICS, INC. 1818910 ALTRX NEUT 32IDX48OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
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Catalog Number 122132048 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Anemia (1706); Unspecified Infection (1930); Tissue Damage (2104); Joint Dislocation (2374)
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Event Date 03/26/2012 |
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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Pfs and medical records received.Pfs and medical records received.Pfs alleges dislocation, infection, muscle damage, fracture of the trochanter and anemia.After review of medical records for the mdr reportability, patient was revised to address peri-implant infection.Operative findings reported of copious purulent materials, infected nonunion of the greater trochanteric area, cable wire was noted loose also with the femoral component.Radiographic evaluation showed a posterior hip dislocation.Clinical notes reported of instability of left hip due to dislocation.Doi: (b)(6) 2011- dor: (b)(6) 2012 (left hip).
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Manufacturer Narrative
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Product complaint # = > pc-(b)(6) investigation summary = > no device associated with this report was received for examination.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 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.Udi: (b)(4).
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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 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: no device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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