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 Nerve Damage (1979); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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, "high risk of positive trendelenburg test after using the direct lateral approach to the hip compared with the anterolateral approach a single-centre, randomized trial in patients with femoral neck fracture" written by t.O.Ugland, g.Haugeberg, s.Svenningsen, s.H.Ugland, o.H.Berg, a.H.Pripp, and l.Nordlestten published by the bone and joint journal 2019 was reviewed.The article's purpose was to compare the functional outcome of two different surgical approaches to the hip in patients with a femoral neck fracture treated with a hemiarthroplasty.Data was compiled from 150 patients who were treated between february 2014 and july 2017.Trendelenburg test and hip disability osteoarthritis outcome scores were utilized to measure outcomes.Results were 11 patients in direct lateral group had a positive trendelenburg and those reported worse hoos scores compared with patients with a negative trendelenburg test.Implants utilized were all depuy.This complaint captures the adverse events/complications possibly associated with the implant use.The article reports mortality rates but does not relate the deaths to use of implants.Depuy products: corail cementless collared stem, bi-polar head with 28 mm articul/eze femoral head.Adverse events/complications: prosthetic joint infection (treated with surgical intervention of "revision without explantation").Intraoperative fracture (narrative utilizes term "during reaming" but surgical procedures indicate broaches were utilized - healed without intervention).Late periprosthetic fracture (healed without intervention).Nerve injury (attributed to intramedullary spinal meningioma discovered on mri scan).

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.Corrected: e1.

• 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: 11077260
• MDR Text Key: 223771936
• Report Number: 1818910-2020-27655
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• 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: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention