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

Catalog Number 3095040

Device Problem Chemical Problem (2893)

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

Event Date 09/29/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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

It was reported that during a total knee arthroplasty, the said product smartset ghv 40g cement was opened and noticed the powder pack has hardened within.Surgeon was notified and the product was immediately taken aside.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: during a total knee arthroplasty, the said product smartset ghv 40g cement was opened and noticed the powder pack has hardened within.Surgeon was notified and the product was immediately taken aside the product was not returned to depuy synthes, however photos were provided for review.See attachment [(b)(4): image of product and sticker].The photo investigation found clumps of dry cement powder tossed on an opened tyvek package, however with the information provided is not possible to determine when this happened as the received condition remains unknown and the cement powder could have been manipulated or in unfavorable conditions before the photograph.A retain sample test was performed please refer to attachment [(b)(4) report] for the full report on lot# 3986438: the cement mixed and behaved as expected for the product type and met the appropriate control specification (ref ms-010 smartset ghv gentamicin bone cement master specification).Setting time was tested using tm-t150.The recorded setting met the control specification of 8.5 ¿ 12.5 (8 min 30s to 12 min 30s).As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was unconfirmed.As the observed condition of the [smartset ghv gentamicin 40g] would not 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 : the mre found two product non-conformances on this lot, neither of which had an adverse effect on the performance of the cement.

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.

Event Description

Additional information was received and stated that upon opening the box and found out the powder was hardened.The cement was not used and was immediately changed.The temperature reported upon opening the box was around 16-18 degrees celsius, standard or temperature.

• Brand Name: SMARTSET GHV 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: 17885666
• MDR Text Key: 325083851
• Report Number: 1818910-2023-20402
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: OUS - SIMILA
• 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,Followup
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• 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: 3986438
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2022
• 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