MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSET GHV GENTAMICIN 40G BONE CEMENT : BONE CEMENT

Catalog Number 3095040

Device Problems Fluid Leak (1250); Tear, Rip or Hole in Device Packaging (2385); Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2020

Event Type  Malfunction  

Manufacturer Narrative

Product complaint# (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A bilateral attune case was done today in (b)(6). Before implanting the implant, an opening was found on the ghv cement (ref: 3095-040) inner sterile pack while the outer layers were perfectly sealed. Cement powder is leaking out from the sterile pack. However the issue was noticed and the cement is discarded before passing it to the scrub nurse. Another pack of cement in good condition was used to replace the faulty one. Was surgery delayed due to the reported event? no. Was procedure successfully completed? yes. Were fragments generated? unknown. If yes, were they removed easily without additional intervention? unknown. Patient status/ outcome / consequences: no. Was other medical intervention (e. G. X-rays, additional procedures, prescriptions, otc, revision) required: unknown. Is the patient part of a clinical study: unknown. Ip-(b)(6). Device property of: none. Device in possession of: none. By checking this box i certify that all information that are known/available has been disclosed. If any new information will be made available, the additional information will be submitted through cst. True.

• Brand Name: SMARTSET GHV GENTAMICIN 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; 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: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10279788
• MDR Text Key: 203894872
• Report Number: 1818910-2020-15964
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (Y/N): N
• Reporter Country Code: MY
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/05/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 07/15/2020
• 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: 9292938
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/18/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 12/05/2019
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial