MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 15MM PROSTHSIS, HIP, SMI-CONSTRAIND, UNCMNTD, MTL/PLYMR, NN-PRS, CALICUM-PHSPHT

Model Number 71332515

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Injury (2348)

Event Date 10/25/2019

Event Type  Injury  

Event Description

It was reported that revision surgery was performed for the third time. Aseptic loosening. Hip prepped and draped, jointly opened, specimens taken. Joint lavaged and debrided intensely. The femoral head removed, poly liner and cup and screws removed. Existing socket reamed to a bleeding bone bed. Implant trialed, joint lavaged again with hydrogen peroxide and more saline. Definitive acetabular implant inserted with bone cement. Tripolar liner/head trialed via reduction, hip stable, definitive tripolar implants inserted and hip reduced, hip closed. No more information is available.

• Brand Name: REF SPHER HEAD SCREW 15MM
• Type of Device: PROSTHSIS, HIP, SMI-CONSTRAIND, UNCMNTD, MTL/PLYMR, NN-PRS, CALICUM-PHSPHT
• 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; memphis, TN 38116 ; 0447940038
• MDR Report Key: 9360066
• MDR Text Key: 167548577
• Report Number: 1020279-2019-04133
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K990666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/10/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 71332515
• Device Catalogue Number: 71332515
• Device Lot Number: 13MM11402
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/05/2020
• 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