MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP SYNERGY IMPLANT; PRSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMRL, MTL/PLYACTAL

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 02/26/2020

Event Type  Injury  

Event Description

It was reported that the patient had bilateral synergy stems with reflection cups, poly liners and ceramic heads since 1998.Right hip revised in 2018 with multiple surgeries and infection.It is unknown devices explanted.

• Brand Name: HIP SYNERGY IMPLANT
• Type of Device: PRSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMRL, MTL/PLYACTAL
• 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: sarah freestone ; 1450 brooks road
• MDR Report Key: 9869656
• MDR Text Key: 184640239
• Report Number: 1020279-2020-00987
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention