MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID US CERAMIC LINER 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number 71338952

Device Problem Fracture (1260)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 12/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported a revision hip surgery was performed due to implant fracture.

Manufacturer Narrative

The associated complaint device was not returned for evaluation.

• Brand Name: R3 36MM ID US CERAMIC LINER 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• 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: claudia de santis ; 1450 brooks road; memphis, TN 38116 ; 0416283206
• MDR Report Key: 6212813
• MDR Text Key: 63518374
• Report Number: 1020279-2016-00987
• 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
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2017

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: Physician
• Device Expiration Date: 07/28/2019
• Device Catalogue Number: 71338952
• Device Lot Number: 09GT33919
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/30/2009
• 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: 48 YR
• Patient Weight: 102