MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Embolism (1829); Neurological Deficit/Dysfunction (1982); Loss of Range of Motion (2032); Skin Irritation (2076); Respiratory Failure (2484)

Event Date 01/05/2001

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).

Event Description

Literature article entitled ¿fat embolism after uncemented total hip arthroplasty".Literature article entitled, ¿fat embolism after uncemented total hip arthroplasty¿ by constantinos d.Apostolou, md, et al, published by clinical orthopaedic related research (2002), no.398, pp.153-156 was reviewed for mdr reportability.The authors present a (b)(6) year old woman who had a severe fat embolism syndrome develop after an uncemented total hip arthroplasty.A (b)(6) year-old woman was admitted to the authors¿ institution for painful osteoarthritis of the left hip.From the medical history, the patient was a hepatitis b carrier attributable to a blood transfusion after a hysterectomy 30 years previously.The patient also had two episodes of gastrorrhagia related to aspirin intake, 9 and 10 years previously, respectively.The patient had osteoporosis and was being treated with calcium carbonate and calcitonin.After admission to the hospital, the patient had a preanesthetic medical evaluation including electrocardiography, plain radiographs of the chest, and laboratory tests such as urea, sodium, potassium, creatinine, blood sugar, and complete blood count.The hematocrit was 38.6% and hemoglobin was 12.6 g/dl.The results of other laboratory tests including liver function tests such as transaminases and bilirubin direct and total were within normal limits.The patient had a total hip arthroplasty using an uncemented femoral stem type aml 5/8 (depuy, leeds, england).Spinal anesthesia was used.There was no intraoperative complication.One hour after the end of the operation, the patient had chest pain, confusion, and excitation.Her blood pressure was 130/90, heart rate was 98 beats per minute, hematocrit was 38%, po2 was 59.2 mm hg, pco2 was 28 mm hg, and saturation was 90.3%.After 2 hours, the patient went into a coma (glasgow coma scale 6).Three hours after the end of the operation, the patient was intubated and was transferred to the intensive care unit.On the first postoperative day, plain radiographs of her chest showed a snowstorm pattern of acute respiratory deficiency syndrome and the hematocrit suddenly decreased to 17%.On the third postoperative day, a petechial rash was present in the upper part of the patient¿s body, neck, and conjunctiva.Using the criteria of gurd7 a diagnosis of fat embolism was established.The patient had supportive therapy in the intensive care unit for 32 days.Computed tomography scans of the brain showed no significant findings and magnetic resonance imaging scans showed spotty areas of high intensity on t2-weighted images (fig 2), findings consistent with those of other reports.6,16 the patient had mechanical ventilation for 24 days.The overall length of hospital stay was 130 days.At the latest follow-up, 12 months postoperatively, the patient had residual emotional difficulties, she walked with a cane, and had decreased hip function attributable to heterotopic ossification.Hip range of motion included 70 flexion, 0 extension, 25 abduction, 15 adduction, 20 external rotation, and 10 internal rotation.The patient was allowed daily activities with mild limitations.The current patient had a severe, potentially fatal, fat embolism syndrome developed and required mechanical ventilation for 24 days because of the severity of the condition.This patient survived most likely because of early administration of supportive therapy.Other reasons for the favorable outcome include the patient¿s healthy background and young age.

Manufacturer Narrative

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.H10 additional narrative: corrected: h6.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 code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 9107049
• MDR Text Key: 163939965
• Report Number: 1818910-2019-105344
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 09/23/2019
• Supplement Dates Manufacturer Received: 09/24/2019
• Supplement Dates FDA Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention