MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DHOXSA 54MM LINER; PRSTHSS,HIP,HEMI,TRUNNIONBRNG,FMRL,MTLPLYCTL

Catalog Number 71343433

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Dislocation (2374)

Event Date 01/15/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to dislocation.

Manufacturer Narrative

(b)(4).Dear ladies and gentlemen, following receipt of additional information concerning this case it has been determined that the initial report was submitted in error.Please therefore disregard this report.This issue was already reported under 1020279-2018-00074.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: DHOXSA 54MM LINER
• Type of Device: PRSTHSS,HIP,HEMI,TRUNNIONBRNG,FMRL,MTLPLYCTL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poettker ; 1450 brooks road; memphis, TN
• MDR Report Key: 7207120
• MDR Text Key: 97797002
• Report Number: 1020279-2018-00070
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2018

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 Expiration Date: 10/22/2021
• Device Catalogue Number: 71343433
• Device Lot Number: 11KM13178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2018
• Initial Date FDA Received: 01/19/2018
• Supplement Dates Manufacturer Received: 01/15/2018
• Supplement Dates FDA Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2011
• 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): Hospitalization; Other; Required Intervention