MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID US CRMC LINER 54; REFLECTION CERAMIC ACETABULAR SYS.

Catalog Number 71338954

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 06/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) customer indicated that there is no product/device to be returned for investigation analysis.

Event Description

It was reported revision surgery was performed due to pain and squeaking.

• Brand Name: R3 36MM ID US CRMC LINER 54
• Type of Device: REFLECTION CERAMIC ACETABULAR SYS.
• 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: yagna angirish ; 1450 brooks rd; memphis, TN 38116 ; 9013995009
• MDR Report Key: 5778661
• MDR Text Key: 49058237
• Report Number: 1020279-2016-00537
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: P030022/S008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2018
• Device Catalogue Number: 71338954
• Device Lot Number: 08GT22381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2008
• 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
• Patient Outcome(s): Hospitalization; Required Intervention