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 Pulmonary Embolism (1498); Hematoma (1884); Pain (1994); Pneumonia (2011); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

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.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.(b)(4).

Event Description

"literature article entitled, ¿displaced intracapsular neck of femur fractures in mobile independent patients: total hip replacement or hemiarthroplasty?¿ by ben squires and gordon bannister, published by injury: international journal for the case of the injured (1999), vol.30, pp.345-348, was reviewed.The aim of this study was to compare the outcome of total hip replacement (thr) with hemiarthroplasty in mobile and socially independent patients with displaced intracapsular fractured neck of femur.This study uses competitor and depuy products.Implanted depuy products: 16 charnley thas including a polyethylene cup cemented with unknown cement, a 22-mm femoral head, and a cementless charnley femoral stem.There were 16 competitor thas.All hemiarthroplasty devices were competitor products.Results: this complaint will only capture the results for thas.The authors provided manufacturer information regarding postoperative dislocations.The number of depuy products associated with the remaining results is unknown.There were no revisions noted within the text of this study.2 dislocations- 1 treated with open reduction and 1 treated with closed reduction.1 pulmonary embolism- treatment unknown 2 wound hematomas- treatment unknown 1 chest infection- coded as pneumonia.Treatment unknown 1 patient with limb asymmetry that caused a slight limp leading to postoperative patient dissatisfaction-no revision required 3 patients had a hhs of ¿poor¿.These patients had postoperative walking difficulty, a decrease in hip joint range of motion, and required assistance to perform adls and/or relocation to a nursing home.Captured in this complaint: charnley polyethylene cup: implant dislocation.22-mm femoral head: implant dislocation.Charnley stem: no reported product problem.Patient harms: pain, medical device site joint range of motion decreased, walking difficulty, limb asymmetry, surgical intervention, pneumonia, hematoma, pulmonary embolism".

• 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: 9410488
• MDR Text Key: 184841443
• Report Number: 1818910-2019-120168
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• 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: 11/12/2019
• 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