Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Fracture (1260)
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Patient Problems
Hemorrhage/Bleeding (1888); Pain (1994); Physical Asymmetry (4573)
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Event Date 01/01/2023 |
Event Type
Injury
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Event Description
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It was reported that in 2017, the patient underwent the surgery via tha for oa for the right hip joint with the stem in question.And in 2019, the patient underwent a tha for oa for the left hip joint with an unknown implant.In 2020, when the patient stood up from a chair, he felt a sudden onset of sharp pain in his right lower back and presented to the emergency room.Upon examination, moderate pain in the right inguinal region, shortening and external rotation of the right lower limb, and joint hemorrhage were revealed.It was also confirmed that the stem neck was broken.There were no associated overt traumatic events.In addition, it is unknown whether the implants other than reported products used in the surgery are jj products or not.No further information is available.
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Manufacturer Narrative
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Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Search Alerts/Recalls
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