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

Catalog Number UNK HIP FEMORAL STEM

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

Patient Problems Hemorrhage/Bleeding (1888); Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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.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.(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, ¿vascular complications in total hip replacement¿ by j.Fruhwirth, et al, published by trauma surgeon (1997), vol 100, pp.119-123, was reviewed.This article reviews 7 vascular complications during tha.Of the 7 patients, 2 were implanted with depuy duraloc acetabular components and an unknown femoral stem.These patients are labeled 60 yo female and 64 yo male.This parent (b)(4) contains the product and adverse event information for the 60/yo female.The information associated with the (b)(6) male is provided in the attached guidance document and linked to this pc.Captured in this complaint: duraloc cup and locking ring, acetabular screw, liner, head, and unknown femoral stem coded for vascular injury.(b)(6) female patient revised with duraloc cup with locking ring, liner, acetabular screw, head, and stem.The manufacturer of the primary implant components is unknown.The patient experiences an intraoperative hemoperitoneum of the external iliac artery and vein caused by the acetabular screw.There was minor bleeding into the pelvic cavity, no transfusion was required.Treatment was suturing of the artery.The manufacturer of the suture was unknown.The components were left in situ and the patient had no further complications.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9325518
• MDR Text Key: 184988219
• Report Number: 1818910-2019-115572
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR