MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL

Catalog Number 71335552

Device Problems Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Weakness (2145); No Information (3190)

Event Date 01/01/1901

Event Type  Injury  

Event Description

Right hip ((b)(6) 2015) - patient states the top part of the implant is breaking away from her body.Patient has weakness in that hip.Patient has been told to have revision surgery but patient hasn't decided if she wants to do that at this time.

Manufacturer Narrative

[(b)(4)].

Manufacturer Narrative

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

• Brand Name: R3 3 HOLE ACET SHELL 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL
• 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: kenney mccaster ; 1450 e. brooks rd.; memphis, TN 38116
• MDR Report Key: 6886032
• MDR Text Key: 87161804
• Report Number: 1020279-2017-00787
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/29/2018

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: No Information
• Device Catalogue Number: 71335552
• Device Lot Number: 15GW21451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/22/2017
• Initial Date FDA Received: 09/22/2017
• Supplement Dates Manufacturer Received: 09/22/2017; 09/22/2017; 09/22/2017
• Supplement Dates FDA Received: 12/05/2017; 12/19/2017; 01/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2015
• 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: 66 YR
• Patient Weight: 68