MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP IMPLANT

Device Problem Insufficient Information (3190)

Patient Problems Foreign Body Sensation in Eye (1869); Pain (1994)

Event Date 01/10/2017

Event Type  Injury  

Manufacturer Narrative

Customer indicated that there is no product/device to be returned for investigation analysis.

Event Description

Pt c/o clunking sensation in left hip and increasing pain at lateral aspect of hip over abductors as well as leg length discrepancy; left being longer than right requiring left hip replacement revision.

Manufacturer Narrative

Customer indicated that there is no product/device to be returned for investigation analysis.

• Brand Name: HIP IMPLANT
• Type of Device: HIP IMPLANT
• 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: claudia de santis ; schachenallee 29; aarau 5001 ; SZ 5001 ; 9013995009
• MDR Report Key: 6298562
• MDR Text Key: 66431891
• Report Number: 1020279-2017-00082
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 07/28/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2017
• Initial Date FDA Received: 02/02/2017
• Supplement Dates Manufacturer Received: 02/02/2017
• Supplement Dates FDA Received: 07/28/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 103