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 Pulmonary Embolism (1498); Hematoma (1884); Unspecified Infection (1930); No Code Available (3191)

Event Date 04/22/2013

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.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.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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)].

Event Description

"literature article entitled, ¿a comparison of the use of uncemented hydroxyapatite-coated bipolar and cemented femoral stems in the treatment of femoral neck fractures¿ by k.R.Bell, et al, published by the bone and joint journal (march 2014), vol, 96-b, no.3, pp.299-305, was reviewed.The primary aim of this study was to determine whether a difference in the all-cause rate of further surgery varied between a conventional cemented taper-slip femoral stem and an uncemented ha-coated stem.The secondary aims were to assess whether there are any differences in operating times, complication rates and mortality between these components.Implanted products: 70 hemiarthroplasties with corail stems with a bipolar femoral head compared to 112 hemiarthroplasties using a competitor stem and head.Results: complications: 1 pulmonary embolism.11 unspecified respiratory infections- treatment unknown.Coded as infection.3 wound hematomas- treatment unknown.4 superficial infections treated with oral antibiotics.7 intraoperative femur fractures treated with cerclage.Reoperations/revisions: 3 total.3 deep infections.2 treated with i &d.1 treated with 2-stage revision of the stem and head.This complaint captures the corail stem and bipolar head.The authors provide information attributing specific events to the corail stem and head.All adverse events attributed to the competitor products are not included on this complaint.".

• 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
• 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: 9256798
• MDR Text Key: 178255571
• Report Number: 1818910-2019-113115
• Device Sequence Number: 1
• Product Code: KWY
• 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,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 10/30/2019
• 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