MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SMARTSET GHV GENTAMICIN 40G; BONE CEMENT : BONE CEMENT

Catalog Number 3095040

Device Problems Difficult to Open or Remove Packaging Material (2922); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint : (b)(4).Dmf# - 13704.Trade name gentamicin sulphate.Active ingredient(s) gentamicin sulphate.Dosage form - powder.Strength 1.0g active in our cements.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the bag with the powder-component sticks together with the outer packaging and cannot be removed.No adverse patient consequences, no surgical delay reported.

Manufacturer Narrative

Product complaint # (b)(4).Mfr# 1818910-2022-14779 is being retracted since it was found to be a duplicate of mrf# 1818910-2022-14882.Mfr# 1818910-2022-14882 will be kept for investigation purposes.

• Brand Name: SMARTSET GHV GENTAMICIN 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15148666
• MDR Text Key: 304343433
• Report Number: 1818910-2022-14779
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 3095040
• Device Lot Number: 3660082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/02/2022
• Supplement Dates Manufacturer Received: 08/02/2022
• Supplement Dates FDA Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2021
• 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