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 Unspecified Infection (1930); Myocardial Infarction (1969); Thrombosis/Thrombus (4440); Renal Impairment (4499); Limb Fracture (4518); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/14/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).(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.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: kaszuba sv, behrens km, anderson cb, gordon ac.A workflow change in anterior approach total hip arthroplasty leads to improved accuracy of biomechanical reconstruction without increased risk of complications.Arthroplasty today.2021 jul 15;10:99-104.Doi: 10.1016/j.Artd.2021.06.007.Pmid: 34337115; pmcid: pmc8318915.Objective and methods: authors performed a retrospective review of 267 direct anterior approach (daa) total hip arthroplasty (tha) with comparison of workflow modifications, addressing the standard acetabulum first (af) technique (132 hips) versus femur first (ff) technique (135 hips), assessing the precision of biomechanical hip reconstruction and clinical outcomes between the af and ff techniques for a minimum 1-year follow-up.Five different femoral stems were used in the study participants: four from depuy (actis (126 hips), corail (101 hips), c-stem (29 hips), and summit (6 hips)) and one competitor stem (5 hips).No information was provided with respect to femoral head details, nor was any information given with regard to acetabular cup and liner configurations or manufacturer(s).Individual patient information was not broken out into specific case number or age/gender demographics.Results: the ff group demonstrated significantly more accurate and more precise reconstruction of horizontal and vertical hip centers, femoral offset, and leg length.There was no significant difference in operative time, hemoglobin change, complication rate, or survey scores between the two groups.Complications (af group): 1: intraoperative calcar femur fracture, treated with 2 cable cerclage orif.1: intraoperative fracture, stem perforation of femur, treated with trochanteric resection and use of longer stem.1: infection, treated with i&d and head/liner exchange.2: infection, treated with simple i&d (no implant exchange reported).1: deep vein thrombosis, treated medically with rivaroxaban.1: myocardial infarction treated with percutaneous coronary intervention complications (ff group): 1: infection resulting in septic acetabular component loosening, requiring a revision (no details provided).1: acute kidney injury and symptomatic hyponatremia during the postoperative recovery course (no treatment or recovery details were provided).

Manufacturer Narrative

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.

• 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): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15065062
• MDR Text Key: 296224833
• Report Number: 1818910-2022-13502
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• 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: 08/23/2022
• 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
• Treatment: UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention