MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID INTL DLT CER LNR 52MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71331752

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 02/13/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed on the patient due to an infected left thr.Smith and nephew liner explanted.Other devices explanted are competitor devices.No complications reported.

Manufacturer Narrative

The associated complaint device was not returned.A clinical evaluation was conducted and it has been communicated via email that no relevant supporting clinical information will be provided, and there is no report of the patient's current condition.Therefore based on insufficient information, no further clinical assessment can be performed at this time.Without the actual product involved and/or device information, 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.We consider this investigation closed.

• Brand Name: R3 36MM ID INTL DLT CER LNR 52MM
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8400123
• MDR Text Key: 138120540
• Report Number: 1020279-2019-00966
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/17/2019

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 Catalogue Number: 71331752
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/07/2019
• Supplement Dates Manufacturer Received: 02/13/2019
• Supplement Dates FDA Received: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention