MAUDE Adverse Event Report: DEPUY CMW - 9610921 DEPUY CMW 3G GENTAMICIN 40G; BONE CEMENT : BONE CEMENT

Catalog Number 3335040

Device Problem Chemical Problem (2893)

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

Event Date 10/03/2023

Event Type  malfunction  

Event Description

Preparation of cement for knee prosthesis.Room temperature is normal.However, cement sets very quickly, time less than 8 minutes for low viscosity.Use of additional dose because the cement sets too quickly.No modification of the storage link, nor in the transport between the pharmacy and the operating room.

Manufacturer Narrative

(b)(6) dmf# - 13704 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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary - no device associated with this report was received for examination.According to the information received, "preparation of cement for knee prosthesis.Room temperature is normal.However, cement sets very quickly, time less than 8 minutes for low viscosity." lot: 4147052 manufacturing date: (b)(6) 23 expiry date: (b)(6) 26 quantity: 2080 product checked: retained samples.Required testing: tm-t150 cement setting time there are no non-conformances associated with this batch.The samples returned were tested in a temperature and humidity-controlled laboratory lot: 4147052 dough time: 2min 38s (5 min 30s max) mix characteristics: soft setting time: 8min 39s (7 min 30s to 11min) the cement mixed and behaved as expected for the product type and met the appropriate control specification (ref: ms-006 master specification: depuy cmw 3g gentamicin bone cement).A manufacturing record evaluation was performed for the finished device product 3335040, lot 4147052, and no non-conformances / manufacturing irregularities were identified.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 (b)(4), lot 4147052, and no non-conformances / manufacturing irregularities were identified.

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 the ampoules are broken in the cup then the powder is added and mixed.Mixing 20 to 30 seconds.Between mixing and application was 6-7 minutes whereas normally it is 13 - 15 minutes.The cement was reported to set too quickly.

• Brand Name: DEPUY CMW 3G 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: 17986044
• MDR Text Key: 326282564
• Report Number: 1818910-2023-21543
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: OUS - SIMILA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3335040
• Device Lot Number: 4147052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2023
• 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