MAUDE Adverse Event Report: SYNTHES GMBH TRAUMACEM V+ BONE CEMENT INJECTABLE

Catalog Number 07.702.040S

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Date 12/19/2023

Event Type  malfunction  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, the patient underwent an unknown surgery with tfna implants and the cement.During the surgery, when the surgeon inserted tfna implants and injected the cement, the cement leaked into the joint.Although the products were used according to the surgical technique and the guidewire did not perforate the bone head, a small amount of cement leaked from the tip of the bone head.The surgery was completed because the amount of cement leaked was little.The surgeon is of the opinion that since no perforation of the bone head occurred, it is possible that there was originally a fracture in the bone head from which the cement leaked out.The surgery was completed successfully with no surgical delay.No further information is available.This report is for one (1) traumacem v+ bone cement injectable.This is report 1 of 1 for complaint (b)(4).

• Brand Name: TRAUMACEM V+ BONE CEMENT INJECTABLE
• Type of Device: BONE CEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SALZBURG; vorgartenstrasse 206b; wien 1020 ; AU 1020
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18494768
• MDR Text Key: 333142439
• Report Number: 8030965-2024-00706
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 07611819453425
• UDI-Public: (01)07611819453425
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170802
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.702.040S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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