MAUDE Adverse Event Report: SMITH & NEPHEW, INC.; TRIAL LINER HIP PROSTHESIS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 05/03/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a revision surgery was performed to remove a trial liner and implant a size 42 cup.

Manufacturer Narrative

The associated complaint device was not returned.The clinical/medical team concluded based on the information provided it has been concluded that a procedural related event is highly likely in this case.Unable to determine patient impact or further risk based on details provided.No further clinical assessment is warranted at this time.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Type of Device: TRIAL LINER HIP PROSTHESIS
• 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: yagna angirish ; 1450 brooks rd; memphis, TN 38116 ; 9013995009
• MDR Report Key: 5667036
• MDR Text Key: 45522930
• Report Number: 1020279-2016-00412
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2016

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?: Yes
• Initial Date Manufacturer Received: 05/03/2016
• Initial Date FDA Received: 05/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/19/2016
• 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