MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSET GHV GENTAMICIN 40G BONE CEMENT : BONE CEMENT

Catalog Number 3095040

Device Problems Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2020

Event Type  Malfunction  

Manufacturer Narrative

Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Inner packing damaged. It was reported that during the surgery of total knee replacement operation, opened the out-box, noted the inner packing was damaged (one part was not sealed) as the photos show. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information could be provided.

• Brand Name: SMARTSET GHV GENTAMICIN 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10364442
• MDR Text Key: 201605982
• Report Number: 1818910-2020-17537
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (Y/N): N
• PMA/PMN Number: K033563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 08/04/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: 3095040
• Device LOT Number: 9400183
• Was Device Available For Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/15/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 03/12/2020
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 08/04/2020 Patient Sequence Number: 1

Treatment

SMARTSET GHV GENTAMICIN 40G