MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN OXINIUM HEAD; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 09/05/2017

Event Type  Injury  

Event Description

It was reported a revision hip surgery due to infection.R3 hole cup, r3 liner, oxinium head and echelon stem were exchanged.

Manufacturer Narrative

The associated complaint device was not returned for evaluation please review attached for investigation results.(b)(4).

Event Description

Pieces 1h and alpoly cup were removed as well.No part number neither lot number provided.

• Brand Name: UNKNOWN OXINIUM HEAD
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• 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: markus poektter ; 1450 brooks road; memphis, TN
• MDR Report Key: 6890725
• MDR Text Key: 87220576
• Report Number: 1020279-2017-00800
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2017
• Initial Date FDA Received: 09/25/2017
• Supplement Dates Manufacturer Received: 09/05/2017
• Supplement Dates FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Congenital Anomaly; Hospitalization; Required Intervention
• Patient Age: 50 YR