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Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problems
Failure of Implant (1924); Pain (1994); Seroma (2069)
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Event Date 01/29/2024 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).G2.Report source: germany.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Event Description
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It was reported that the patient felt pain in the left thigh approximately two and a half years post- implantation while getting out of the car.The x-ray shows the fracture of the revitalization shaft in the area of the cone directly at the connection point with the neck section.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.D10.Revitanâ®, proximal part, cylindrical, uncemented, 55, taper 12/14 item# 0100402055 lot# 3063962e21.Sulox, head, s¸ 28/-3.5, taper 12/14 item# 172805 lot#3068522d21.Unknown depuy synthes trochanteric plate.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Event Description
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It was reported that the patient returned to the clinic with severe pain in the hip without trauma approximately two and a half years post-implantation.A cone fracture was identified on x-ray and a second revision of the head and stem was performed; during which, a transfemoral approach was used to release the distal body, and the revision was completed without complications.Due diligence is in process and additional information on the reported event is unavailable at this time.
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Search Alerts/Recalls
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