MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 SMARTSET GMV 40G US EO; BONE CEMENT : BONE CEMENT

Catalog Number 545050501

Device Problem Chemical Problem (2893)

Patient Problem Insufficient Information (4580)

Event Date 08/22/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # : (b)(4).F# - (b)(4).Trade name gentamicin sulphate.Active ingredient(s) gentamicin sulphate.Dosage form - powder.Strength 1.0g active in our cements.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 the gmv cement hardened too quickly and was not able to shoot in a cement gun.

Event Description

Additional information received.A.How was the cement prepared for use? it was mixed in a mixing tower for 1 minute.It was then mixed for 30 seconds in a mixing tower the next attempts & still hardened too quickly before putting into a cement gun.B.What equipment was used to prepare / mix the cement? hospital-owned stryker mixing tower.C.What was the timing to mix and the time between mixing and setting? mix was 1 minute and time between mixing and setting was 2-3 minutes.D.What equipment was used to deliver the cement? was going to be a cement gun.E.Can you provide the quantity used of the cement product? qty of 5 was used in the procedure.

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.An analysis of the product could not be performed since a physical sample was not received for evaluation.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.However, if the product is received at a later date, the investigation will be updated as applicable.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.According to the information received, it was reported that the gmv cement hardened too quickly and was not able to shoot in a cement gun.This happened in 3 attempts mixing cement during the case.Afterwards a total mix was done with a batch of cement and the same thing happened.It's almost like the gmv cement is acting like the ghv cement.A manufacturing record evaluation was performed for the finished device product code:545050501 lot number:4047303, and no non-conformances / manufacturing irregularities were identified.Lot: 4047303.Manufacturing date: 23 jan 23.Expiry date: 31 dec 24.Quantity: (b)(4).Product checked: retained samples.Required testing: tm-t150 cement setting time there are no non-conformances associated with this batch.Dough time: 02 min 48 secs.Mix characteristics: ok.Setting time: 10 min 29 sec.The cement mixed and behaved as expected for the product type and met the appropriate control specification (ref (b)(4).Smartset gmv gentamicin bone cement master specification).Setting time was tested using tm-t150.The recorded setting met the control specification of 9.0 ¿ 13.5 (9 min to 13 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 product code:545050501 lot number:4047303, and no non-conformances / manufacturing irregularities were identified.

• Brand Name: SMARTSET GMV 40G US EO
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• 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: 17650007
• MDR Text Key: 322272294
• Report Number: 1818910-2023-17799
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174295
• UDI-Public: 10603295174295
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 545050501
• Device Lot Number: 4047303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2023
• 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: SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
• Patient Sex: Female