SUBCHONDROPLASTY N/A 402.202

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 2020-01-09 for SUBCHONDROPLASTY N/A 402.202 manufactured by Zimmer Knee Creations, Inc..

Event Text Entries

[174369104] On (b)(6) 2019, a patient underwent a right knee scope with a subchondroplasty. There were no complications reported during the procedure; the patient had no other known pre-existing conditions that may have contributed to the event. The patient experienced increased pain following the subchondroplasty procedure and is in ambulating with crutches. He had follow-up mri which showed increased edema insitu, those images will be reviewed as a part of the investigation. The product was not returned for the investigation, as it remains implanted in the patient. Once additional information becomes available, a follow up report will be submitted. Implant remains in patient.
Patient Sequence No: 1, Text Type: N, H10


[174369105] Patient has increased pain since (b)(6) 2019 scp and scope.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008812173-2020-00001
MDR Report Key9570678
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-01-09
Date of Report2020-01-09
Date of Event2019-08-07
Date Facility Aware2019-12-10
Date Mfgr Received2019-12-10
Device Manufacturer Date2019-07-16
Date Added to Maude2020-01-09
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 Received2020-01-09
Model NumberN/A
Catalog Number402.202
Lot NumberKC06211
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age5 MO
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
101. Other 2020-01-09

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