MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ULTR FST-FIX KNT PSHER/SUTUR CUTT STRT; ACCESSORIES, ARTHROSCOPIC

Catalog Number 72201537

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthritis (1723); Purulent Discharge (1812); Edema (1820); Fever (1858); Inflammation (1932); Pain (1994)

Event Date 12/12/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

An ultr fst-fix knt psher/sutur cutt strt was used during a left knee acl (anterior cruciate ligament) reconstruction and meniscal repair procedure.Approximately a month and a half later, the patient suffered from hydropsy, fever and pain, and was diagnosed with left knee purulent arthritis.The patient was admitted into the hospital and a synovectomy procedure was performed.The inflammation reaction was observed and the site was irrigated for about two weeks.Two months later the site was debrided, including the reconstructed ligament, and (b)(6) were prescribed for two months.One year later another left knee acl procedure was performed.The patient is now in stable condition.The surgeon doesn't think the device caused the infection.

• Brand Name: ULTR FST-FIX KNT PSHER/SUTUR CUTT STRT
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4992660
• MDR Text Key: 22591027
• Report Number: 1219602-2015-00756
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Report Date: 07/13/2015

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 Catalogue Number: 72201537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2015
• 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): Other
• Patient Age: 23 YR
• Patient Weight: 50