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 Insufficient Information (4580)

Event Date 09/26/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Dmf# (b)(4).Trade name gentamicin sulphate.Active ingredient(s) gentamicin sulphate.Dosage form - powder.Strength 1.0g active in our cements.H10 ¿ no 510k as device is not marketed in the united states under this product code, but the same/similar product is marketed in the us under a different product code.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

The complaint is that the cement is setting very quickly, this has happened on a couple of cases over the past few weeks.We were provided with details of the effects of a primary hip case stating the cement set after 4 minutes.This resulted in the surgeon being unable to implant the cemented hip stem correctly and as a result they had to revise the hip.This added an additional 1.5 hours onto the surgery time and the patient had to have a general anaesthetic that they were not expecting.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.According to the information received, "the complaint is that the cement is setting very quickly, this has happened on a couple of cases over the past few weeks." lot: 3980082; manufacturing date: 31 oct 22; expiry date: 30 sep 24; quantity: (b)(4).There was one non-conformance associated with 3980082.The non-conformance would not have had an adverse effect on the performance of the cement.Final micro and sterility tests passed.Product met all quality control acceptance criteria.Product checked: returned samples.Required testing: tm-t150 cement handling.The samples returned were tested in a temperature and humidity-controlled laboratory.Lot: 3980082 (smartset ghv gentamicin); dough time: 43 secs (spec: 1 min 30s max); mix characteristics: thin; setting time: 10 min 02 secs (spec 8 min 30s to 12 min 30 sec).The cement mixed and behaved as expected for the product type and met appropriate specifications (ms-039 smartset gmv gentamicin bone cement).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 3980082, and no non-conformances / manufacturing irregularities related to the malfunction 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 IRELAND UC; loughbeg, ringaskiddy co.; cork FY4 4 QQ; EI FY4 4QQ
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17877610
• MDR Text Key: 325001441
• Report Number: 1818910-2023-20303
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): Y
• Reporter Country Code: UK
• 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
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3095040
• Device Lot Number: 3980082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2022
• 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
• Treatment: DEPUY CMW 1G 40G.; SMARTSET GHV GENTAMICIN 40G.
• Patient Outcome(s): Required Intervention