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 Stroke/CVA (1770); Unspecified Infection (1930); No Code Available (3191)

Event Date 09/19/2018

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.(b)(4).

Event Description

The literature article entitled, "is rigid fixation of the greater trochanter necessary for arthroplasty of intertrochanteric fractures?" written by kee haeng lee , dong hun lee , jong ho noh , and yoon vin kim published by orthopaedics & traumatology: surgery & research accepted by publisher on 19 september 2018 was reviewed.The article's purpose is the review the short-term results of osteosynthesis of the greater trochanter fragments by nonabsorbable ethibond sutures to see if the ethibond suture technique is an efficient method for fixation of the greater trochanter fragments in arthroplasty of intertrochanteric hip fractures.Data was compiled from 47 cases of bi polar hemi-arthroplasties implanted between 2010 and 2016 and depuy and non-depuy implants were utilized.One case was a cemented depuy bipolar hemiarthroplasty with cstem amt hip system.The article does not clarify which specific products are associated with the adverse events.Cement manufacturer is not identified.As the article identifies the implants were bi-polar hemiarthroplasty hip systems, the bipolar head is assumed as either depuy or non-depuy according to the identified hip system.Figure 4 and figure 5 provide radiographic imaging for illustrative purposes, and caption description does not indicate any adverse events associated with products.Depuy products: non-cemented summit tapered hip system, non-cemented aml hip system, cemented cstem amt hip system, bipolar head for each system.Adverse events: cva (interventions not specified but patient ambulatory status declined from community ambulatory with case to non-functional ambulatory).Joint infection (treated by revision with total hip replacement arthroplasty).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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: 10130192
• MDR Text Key: 194707138
• Report Number: 1818910-2020-13356
• 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: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• 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: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention