SUBCHONDROPLASTY N/A UNKNOWN

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 2019-10-22 for SUBCHONDROPLASTY N/A UNKNOWN manufactured by Zimmer Knee Creations, Inc..

Event Text Entries

[163193338] On (b)(6), 2017, a patient underwent an initial subchondroplasty procedure. On (b)(6) 2019, zimmer knee creations became aware of the adverse event of osteoarthritis which resulted in a total knee replacement of the left knee that occurred on (b)(6) 2019. The health care professional assessed the event and determined it was possible related to the subchondroplasty study procedure and not related the accufill implant. The operative notes for the event were requested from the clinical project lead. The product was not returned for the investigation, as it remains implanted in the patient. The dhr was unable to be reviewed, as the lot number for the device related to the event was unable to be confirmed. Device remains implanted.
Patient Sequence No: 1, Text Type: N, H10


[163193339] Subject (b)(4) adverse event of total knee replacement after scp.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008812173-2019-00050
MDR Report Key9217791
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-10-22
Date of Report2019-10-21
Date of Event2019-06-19
Date Facility Aware2019-09-25
Date Mfgr Received2019-09-25
Date Added to Maude2019-10-22
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 Received2019-10-22
Model NumberN/A
Catalog NumberUNKNOWN
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2019-10-22

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