SUBCHONDROPLASTY N/A 514.502

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-10-10 for SUBCHONDROPLASTY N/A 514.502 manufactured by Zimmer Knee Creations, Inc..

Event Text Entries

[161927349] On (b)(6) 2019, a patient underwent a subchondroplasty procedure with no intraoperative complications reported. The patient was then sent to the post-anesthesia care unit, where the woke up normally. Within an hour, the patient began acting differently and was short of breath. A ct scan was taken and an embolus was noted in the patient's brain. Through an initial interview, the sales representative stated that the patient had experienced a stroke post-operatively. The investigation for this event in ongoing. Once additional information becomes available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[161927350] Patient acted differently and experienced shortness of breath after scp procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008812173-2019-00047
MDR Report Key9175771
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-10-10
Date of Report2019-10-07
Date of Event2019-09-10
Date Facility Aware2019-09-10
Date Mfgr Received2019-09-10
Device Manufacturer Date2018-09-05
Date Added to Maude2019-10-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. LEO MUNAR
Manufacturer Street841 SPRINGDALE DRIVE
Manufacturer CityEXTON PA 19341
Manufacturer CountryUS
Manufacturer Postal19341
Manufacturer Phone4848794553
Manufacturer G1ZIMMER KNEE CREATIONS, INC.
Manufacturer Street841 SPRINGDALE DRIVE
Manufacturer CityEXTON PA 19341
Manufacturer CountryUS
Manufacturer Postal Code19341
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameSUBCHONDROPLASTY
Generic NameSCP KIT
Product CodeOJH
Date Received2019-10-10
Model NumberN/A
Catalog Number514.502
Lot NumberKC05449
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age1 YR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER KNEE CREATIONS, INC.
Manufacturer Address841 SPRINGDALE DRIVE EXTON PA 19341 US 19341


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-10

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