MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID US CRMC LINER 52MM; ACETABULAR LINER

Catalog Number 71338952

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 11/10/2014

Event Type  Injury  

Event Description

It was reported that the patient presented with pain and a revision surgery was performed that found the implant had fractured.

Manufacturer Narrative

(b)(4).The associated devices were not returned for evaluation.A review of manufacturing records did not reveal any material or manufacturing deviations that could have contributed to this issue.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: R3 36MM ID US CRMC LINER 52MM
• Type of Device: ACETABULAR LINER
• 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: robert rust ; 1450 brooks road; memphis, TN 38116 ; 9013991624
• MDR Report Key: 4936806
• MDR Text Key: 6040743
• Report Number: 1020279-2015-00499
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030022/S008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2018
• Device Catalogue Number: 71338952
• Device Lot Number: 08FT21058R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2008
• 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
• Treatment: (B)(4); (B)(4); (B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 20 YR
• Patient Weight: 95