MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM XL/+12; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Catalog Number 71343612

Device Problem Insufficient Information (3190)

Patient Problems Deposits (1809); Failure of Implant (1924); Unspecified Infection (1930); Toxicity (2333); Fibrosis (3167)

Event Date 09/30/2015

Event Type  Injury  

Event Description

The patient presented with a preoperative diagnosis of right hip infection.The patient underwent a removal of the right total hip arthroplasty and placement of antibiotic impregnated cement spacer.

• Brand Name: OXINIUM FEM HD 12/14 36 MM XL/+12
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• 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
• MDR Report Key: 6789965
• MDR Text Key: 82556535
• Report Number: 1020279-2017-00622
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03596010520449
• UDI-Public: 03596010520449
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 11/17/2017

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: Health Professional
• Device Expiration Date: 10/11/2020
• Device Catalogue Number: 71343612
• Device Lot Number: 10KM10352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/14/2017
• Initial Date FDA Received: 08/11/2017
• Supplement Dates Manufacturer Received: 07/14/2017
• Supplement Dates FDA Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/14/2010
• 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: 53 YR