Catalog Number UNK HIP ACETABULAR LINER |
Device Problems
Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Anemia (1706); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Joint Dislocation (2374); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)
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Event Date 10/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).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.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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Article entitled "safety and efficacy of total hip arthroplasty in hypothyroid patients¿ written by yuan mingcheng, xiao qiang, ding zichuan, ling tingxian, and zhou zongke published in chinese journal of reparative and reconstructive in october of 2020 was reviewed.The purpose was to summarize the safety of total hip arthroplasties in patient with hypothyroidism.There were two groups of patients (63 hips in each group).All patients were implants with a pinnacle cup and corail femoral stem.Adverse events: 9 patients underwent transfusion due to blood loss.2 patients had post-op liver dysfunction - after intravenous drip of reduced glutathione for injection, the liver function returned to normal on the next day.3 patients had post-op heart failure - the patients returned to normal after reducing the amount of fluid infusion and slowing down the rate of fluid infusion.1 patient had a pulmonary infection, and 1 patient had a urinary infection that were cured after anti-infective treatment with antibiotics.3 patients had wound complications which were healed after infrared lamp treatment.105 patients had post-op anemia ¿ treatment not noted.12 patients had post-op dvt ¿ treatment not noted.1 patient was readmitted due to hip adduction and internal rotation dislocation, and was discharged smoothly after successful bedside manual reduction.1 patient sustained an infection.Prosthesis removal + antibiotic bone cement provisional prosthesis implantation.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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Search Alerts/Recalls
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