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

Catalog Number 545050500

Device Problems Fluid/Blood Leak (1250); Device Damaged Prior to Use (2284)

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

Event Type  malfunction  

Event Description

It was reported that, upon delivery to the hospital, the product in question smelled strange, as if the monomer ampoule had cracked and was leaking.It is unclear when the damage occurred.No further information is available.

Manufacturer Narrative

Product complaint # : (b)(4).B3: date of event is an unknown date.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

Event Description

Additional information was received and stated that there were no reports of patient harm.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary :it was reported that on apr.19, 2024, upon delivery to the hospital, the product in question smelled strange, as if the monomer ampoule had cracked and was leaking.It is unclear when the damage occurred, but a j&j¿s distributor mentioned it is being cautious with the product.No further information is available.The product was not returned to depuy synthes, however photos were provided for review.See attachment [photo_(b)(4)_maruki medical system inc.(jo202400173)].The photo investigation revealed that the amber vial is damaged, which may have caused the liquid to spill into the same packaging.Once the product leaves depuy synthes control, it is unknown what environment conditions the packaged products are exposed to during that time.Therefore the suspected cause is traced to transport/storage outside of depuy synthes control.The received condition of the device confirmed the reported allegation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the smartset ghv gentamicin 40g would contribute to the complained device issue.Based on the investigation findings it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a review of the dhr has confirmed that there were no process issues documented that could contribute to the event described.Device history review : a review of the dhr has confirmed that there were no process issues documented that could contribute to the event described.

• Brand Name: SMARTSET GMV GENTAMICIN 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19188613
• MDR Text Key: 341129545
• Report Number: 1818910-2024-09161
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K041656
• 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: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 545050500
• Device Lot Number: 4099212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1