MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

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

Patient Problems Dyspnea (1816); Fever (1858); Hemorrhage/Bleeding (1888); Pain (1994); Tachycardia (2095); Thrombosis (2100); No Code Available (3191)

Event Date 04/13/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #
=
> pc-000771614 h6 device code: no code available (3191) used to capture serious injury.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.

Event Description

The literature article entitled, "deep vein thrombosis after cement intravasation during hip hemiarthroplasty" written by abhay mathur, md, safa c.Fassihi, md, pradip ramamurti, bs, and teresa doerre, md published by arthroplasty today made available online 13 april 2020.The article's purpose was to report on a case of (b)(6) years old woman who received depuy implants for hemiarthroplasty with a cemented stem.Intraoperative techniques were uneventful.On the 1st postoperative day, radiographic images demonstrate serpiginous opacity medial to the shaft of the femur and 10 centimeters from the lesser trochanter.Patient experiences tachycardia and decreased hemoglobin (7.3 grams/deciliter post-op compared to 13.2 g/dl preoperative value), and the patient received one unit of packed red blood cells to improve hemoglobin (increased to 8.9 g/dl).On 2nd postoperative day, patient experiences intermittent tachycardia and received fluid resuscitation but continued to be intermittent tachycardic.On the 3rd postoperative day, patient experienced shortness of breath and a pe was ruled out via ct scan.Patient's fever and tachycardia resolves shortly after.On 5th postoperative day, patient is stable but reports left thigh pain.Doppler reveals a mobile thrombus at confluence of the femoral and profunda femoris veins and a nonmobile thrombus in profunda femoris vein, and it was noted that the two thrombi had distinctly varying density.It was concluded the proximal thrombus was cement that had intravasated during the operation which was impeding venous flow and led to the development of a deep vein thrombus distally.Patient was treated with apixaban and continued with physical therapy.She was discharged on the 7th post operative day with no further symptoms.Depuy products: summit stem, cmw 1 bone cement, cement restrictor, unipolar head adverse events: tachycardia, major bleed (treated by transfusion), shortness of breath, fever, pain, deep vein thrombosis (treated by apixaban).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Provided x-ray images have been reviewed.There was no product problem identified to suggest that error with this depuy device was a factor in the problems reported.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10589440
• MDR Text Key: 208776181
• Report Number: 1818910-2020-20948
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR