MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREADED HOLE COVER; PROSTHESIS, HIP, SEMI-CONSTRAINED,UNCEMENTED,METAL/POLYMER,POROUS

Catalog Number 71336500

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

Patient Problems Fever (1858); Pain (1994)

Event Date 01/02/2018

Event Type  Injury  

Event Description

It was reported a revision surgery was performed due to pain and fever, the tests were non conclusive of infection.

Manufacturer Narrative

The associated complaint device was not returned for evaluation.Please see attached the results of our investigation.(b)(4).

• Brand Name: REF THREADED HOLE COVER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED,UNCEMENTED,METAL/POLYMER,POROUS
• 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 38116
• MDR Report Key: 7184219
• MDR Text Key: 97048193
• Report Number: 1020279-2018-00044
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010197634
• UDI-Public: 03596010197634
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K070756
• 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: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2018
• Device Catalogue Number: 71336500
• Device Lot Number: 08MM13629
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/16/2008
• 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