MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 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 09/25/2023

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

Smartset ghv was highlighted to have a different consistency after mixture.Surgeon described the cement to be lumpy and powdery despite following the cement mixing instructions.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.According to the information received, "smartset ghv was highlighted to have a different consistency after mixture.Surgeon described the cement to be lumpy and powdery despite following the cement mixing instructions." lot: 3986438.Manufacturing date: 09 nov 23.Expiry date: 31 oct 24.Quantity: (b)(4).There were two product non-conformances on this lot, neither of which had an adverse effect on the performance of the cement.The retained samples were tested in a temperature and humidity-controlled laboratory.Dough time: 55 sec.Mix characteristics: as expected.Setting time: 10 min 10 sec.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 part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: a manufacturing record evaluation was performed for the finished device 3095040, lot 3986438, and no non-conformances / manufacturing irregularities were identified.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.According to the information received, "smartset ghv was highlighted to have a different consistency after mixture.Surgeon described the cement to be lumpy and powdery despite following the cement mixing instructions." lot: 3986438, manufacturing date: 09 nov 22, expiry date: 31 oct 24, quantity: (b)(4).There were two product non-conformances on this lot, neither of which had an adverse effect on the performance of the cement.The retained samples were tested in a temperature and humidity-controlled laboratory.Dough time: 55 sec mix characteristics: as expected.Setting time: 10 min 10 sec.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 part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot : a manufacturing record evaluation was performed for the finished device 3095040, lot 3986438, and no non-conformances / manufacturing irregularities were identified.

• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17875828
• MDR Text Key: 324975571
• Report Number: 1818910-2023-20248
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 10/05/2023

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 Operator: Health Professional
• Device Catalogue Number: 3095040
• Device Lot Number: 3986438
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/05/2023
• Supplement Dates Manufacturer Received: 10/11/2023; 11/01/2023
• Supplement Dates FDA Received: 10/12/2023; 11/02/2023
• 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