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Model Number N/A |
Device Problems
Fracture (1260); Migration or Expulsion of Device (1395)
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Patient Problems
Bone Fracture(s) (1870); Hip Fracture (2349); Reaction (2414); Device Embedded In Tissue or Plaque (3165)
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Event Date 08/09/2016 |
Event Type
Injury
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Manufacturer Narrative
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The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.Results - two screws were revised; however, review of photographic evidence shows only one screw had fractured.It is unknown which of the two screws fractured.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 9 states, "fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, and/or excessive weight." this report is number 4 of 4 mdrs filed for the same event (reference 9613350-2016-01189 and 1825034-2016-03621 / 03622 / 03623).
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Event Description
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Patient underwent a hip revision procedure approximately five months post-implantation due to cup migration, screw fracture, and acetabular fracture.The modular head, hip bearing, cup, and screws were removed and replaced.An acetabular buttress was also implanted.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 4 states, ¿loosening, migration, or fracture of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, or excessive activity.¿.
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Event Description
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Patient underwent a hip revision procedure approximately five months post-implantation due to cup migration, screw fracture, and acetabular fracture.It was further reported in operative notes received that clear yellow effusion, granulomatous type synovitis, scar tissue, a pseudoacetabulum, and heterotopic bone were noted.One screw was found to be broken and another had pulled out of the bone.A piece of the fractured screw was retained by the patient.The modular head, hip bearing, cup, and screws were removed and replaced.An acetabular buttress was also implanted.
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Manufacturer Narrative
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Catalog 010000999 lot 3443808.(b)(4).
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Search Alerts/Recalls
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