Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Implants are being reported as a death at this time.The source of the information is literature article.There is limited information regarding the patient's death at this time.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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An article/literature was received entitled "second place award: residents or hip surgeons for the treatment of displaced femoral neck fractures? a 10-year survivorship rate analysis".Literature article entitled "residents or hip surgeons for the treatment of displaced femoral neck fractures? a 10-year survivorship rate analysis" written by fernando diaz dilernia, agustin garcia mansilla, lionel llano, martin buljubasich, jose ignacio onativia, and martin alejandro buttaro.Published by current orthopaedic practice published online/accepted by publisher july/august 2019 was reviewed.The article's purpose was to "analyze the 10-year clinical outcomes, complications, and survivorship rates of patients who had tha for displaced femoral neck fractures operated either by hip surgeons or third or fourth year orthopaedic residents." data retrospectively studied 205 displaced femoral neck fractures operated between 2004-2008.Cement manufacturer(s) were not identified.There were no patient identifiers within the article.The article included both depuy thas and non-depuy thas.The depuy thas included pinnacle and ogee all poly cups and c-stem femoral stem.Assumed depuy acetabular liners and femoral heads will be captured on complaint.Depuy products with known adverse event(s): c-stem femoral stem.Pinnacle acetabular cup.Ogee all poly acetabular cup.Unknown femoral head.Unknown acetabular liner.Adverse events: 12 cases of unknown loosening (acetabular cup and femoral stem).9 cases of dislocation treated with unspecified constrained cup and/or closed reduction.10 cases heterotopic ossification with unspecified treatment.8 cases of infection treated with irrigation and debridement, antibiotics, and retention of products.1 case of bradycardia treated with iv inotropic infusion.4 cases of pulmonary embolism treated with low molecular weight heparin.4 cases of stroke treated with thrombolysis.8 cases of pneumonia treated with antibiotics.8 cases of deep vein thrombosis treated with low molecular weight heparin.5 cases of urinary tract infection treated with antibiotics.1 case of intra-operative blood loss treated with blood.Transfusion.12 cases of femoral bone fracture treated both open reduction and fixation and revision.1 case of cholecystitis treated with a laparoscopy cholecystectomy.3 patients died of cardiorespiratory arrest secondary to pulmonary embolism in the early postoperative period.
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Product complaint#: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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