MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CONT RECON RING 56/52 LFT; MESH, SURGICAL, ACETABULAR, HIP, PROSTHESIS

Catalog Number 71337156

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 08/17/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed to replace implants stryker all poly cup, cpcs stem and head due to infection.

Manufacturer Narrative

The associated complaint devices were not returned for evaluation.The devices were manufactured in 2013, 2014 and 2015.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.Products were sterilized according to sterilization release documentation from quality control.A clinical investigation was conducted and it concluded that all documents provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.The reported infection was the contributing factor to the left tha revision; however without the supporting lab/pathology results, operative notes, and/or explanted components, the source of the infection cannot be confirmed.The patient impact beyond the reported symptoms, left hip revision/first stage, likely antibiotic therapy, and an expected post-op convalescence period cannot be determined.No further medical assessment is warranted at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: CONT RECON RING 56/52 LFT
• Type of Device: MESH, SURGICAL, ACETABULAR, HIP, PROSTHESIS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7881001
• MDR Text Key: 120412058
• Report Number: 1020279-2018-01814
• Device Sequence Number: 1
• Product Code: JDJ
• UDI-Device Identifier: 03596010308290
• UDI-Public: 03596010308290
• Combination Product (y/n): N
• PMA/PMN Number: K962541
• 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: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71337156
• Device Lot Number: 14KM14707
• Date Manufacturer Received: 08/19/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly; Hospitalization; Other