MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE HA CTD ACET SHELL 50MM; ACETABULAR SHELL

Catalog Number 71331950

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 06/01/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6) 2015: the patient presented with swelling and underwent a unenhanced ct of the right hip.Findings: the right hip arthroplasty appears appropriately sited.There is no definite osteolysis adjacent to the acetabula or femoral component.The lobulated collection anterior tot he hip and extending superiorly i the right iliopsoas bursa again noted, unchanged from ct abdomen (b)(6) 2015.The pseudocapsule of the hip prosthesis does appear mildly distended posteriorly.This capsular bulging does not extend to the sciatic nerve.(b)(6) 2015 plasma cobalt 452 nmol/l / plasma chromium 388 nmol/l / whole blood chromium 448 nmol/l / whole blood chromium 220 nmol/l.(b)(6) 2015: the patient underwent a revision of the head/taper sleeve and metal liner to a ceramic head and xlpe liner based on the results from the venogram.

Event Description

It was reported that a revision complete right hip replacement was performed.

Manufacturer Narrative

The associated device was not returned.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.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 3 HOLE HA CTD ACET SHELL 50MM
• Type of Device: ACETABULAR SHELL
• 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: 5272978
• MDR Text Key: 32860513
• Report Number: 1020279-2015-00843
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/18/2015

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: Health Professional
• Device Expiration Date: 12/24/2017
• Device Catalogue Number: 71331950
• Device Lot Number: 07LM16919A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2015
• Initial Date FDA Received: 12/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/27/2007
• 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: 71336650/09EM09453
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR