MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR PLUS HA SO STEM SZ 13 PROSTHESIS,HIP,SEMICONSTRAINED,UNCEMENTED,METALPOLYMER,NONPOROUS,CALICUM

Model Number 71309013

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

Patient Problems Osteolysis (2377); Metal Related Pathology (4530)

Event Date 03/23/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after left bhr tha construct was implanted on (b)(6) 2010, the plaintiff experienced metallosis. A revision surgery was performed on (b)(6) 2020 to treat this adverse event. During the surgery, significant osteolysis was noted around the cup, as well as large collection of brown fluid. Plaintiff outcome is unknown.

• Brand Name: SYN POR PLUS HA SO STEM SZ 13
• Type of Device: PROSTHESIS,HIP,SEMICONSTRAINED,UNCEMENTED,METALPOLYMER,NONPOROUS,CALICUM
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13100979
• MDR Text Key: 284801738
• Report Number: 1020279-2021-08919
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 01/03/2020
• Device Model Number: 71309013
• Device Catalogue Number: 71309013
• Device Lot Number: 09MM02006A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage