MAUDE Adverse Event Report: DEPUY CMW - 9610921 DEPUY/CMW 2G; BONE CEMENT : BONE CEMENT

Catalog Number	545032500
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Dmf# - 13704, trade name ¿ gentamicin sulphate, active ingredient(s) ¿ gentamicin sulphate, dosage form - powder, strength ¿ 1.0g active in our cements.
Event or Problem Description
It was reported that patient underwent a hip surgery on (b)(6) 2024.Four units of antibiotic bone cement did not mix correctly and were wasted.Other cement was used.Procedure was completed successfully.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary antibiotic bone cement - or scrub wasted 4 units of cement - not mixed correctly.The product was not returned to j&j medtech orthopaedics, however photos were provided for review.See attachment 366977-002.Pdf, 366977_su_001 (1)_redacted (1).Pdf.The photographs attached were reviewed, however they do not represent the reported complaint.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.A retained sample test was performed for this product and lot combination.The cement mixed and behaved as expected for the product type and met the appropriate control specification.The overall complaint was not confirmed as the observed condition of the depuy/cmw 2g would not have contributed to the complained 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 reported complaint condition.As part of j&j medtech orthopaedics 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 a manufacturing record evaluation was performed for the finished device product description: depuy/cmw 2g product code: 545032500 lot number: 4306655 and there are no non-conformances associated with this lot.

• Brand Name: DEPUY/CMW 2G
• Common Device Name: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; cornford rd; blackpool IN 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 ; 3035526892
• MDR Report Key: 20363577
• Report Number: 1818910-2024-20719
• Device Sequence Number: 20548026
• Product Code: MBB
• UDI-Device Identifier: 10603295174271
• UDI-Public: (01)10603295174271(17)260930(10)4306655
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K081163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: 545032500
• Device Lot Number: 4306655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEPUY/CMW 2G.; DEPUY/CMW 2G.; DEPUY/CMW 2G.
• Patient Sex: Unknown