MAUDE Adverse Event Report: SYNTHES GMBH VERTECEM V+ CEMENT KIT; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 07.702.016S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 05/08/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3/h6: device history lot: part:07.702.016s.Lot:2h53531.Manufacturing site: werk selzach.Supplier: (b)(4).Release to warehouse date:09 aug 2022.Expiration date: 01 aug 2025.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 depuy synthes reports an event in china as follows: it was reported that this case was referred from the health authority.It was reported that during the operation, when using cement and bone filling consumables, the patient experiences a sudden decrease in heart rate and blood pressure.After receiving emergency treatment from the surgeon, the patient was released from danger.There was no surgical delay and no patient consequences.The procedure was completed successfully.This complaint involves one (1) device.This report is for one (1) vertecem v+ cement kit.This is report 1 of 1 for complaint (b)(4).

• Brand Name: VERTECEM V+ CEMENT KIT
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohackerweg 5; selzach CO 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17021213
• MDR Text Key: 316289741
• Report Number: 8030965-2023-06793
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 07611819376250
• UDI-Public: (01)07611819376250
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.702.016S
• Device Lot Number: 2H53531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female