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 consumer,other report with the FDA on 2019-08-28 for SUBCHONDROPLASTY N/A UNKNOWN manufactured by Zimmer Knee Creations, Inc..

Event Text Entries

[155952995] On 29 july 2019, zimmerbiomet was notified by the fda of an event via medwatch number mw5088155. A patient had reported that after the initial subchondroplasty procedure on (b)(6) 2015, they experienced increased pain, and at follow-up appointments, received steroid injections, physical therapy, and four additional procedures, including a total knee replacement in 2016 and a tka revision in 2017. The patient had two mri images taken in 2015, and a ct in 2016. Additionally, the patient underwent a spinal fusion in 2009. Once additional information becomes available about the event, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[155952996] Patient suffering pain and disability after scp and tka.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008812173-2019-00042
MDR Report Key8940153
Report SourceCONSUMER,OTHER
Date Received2019-08-28
Date of Report2019-08-28
Date of Event2015-03-17
Date Facility Aware2019-07-31
Report Date2019-07-12
Date Reported to FDA2019-07-12
Date Reported to Mfgr2019-07-29
Date Mfgr Received2019-07-29
Date Added to Maude2019-08-28
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 Received2019-08-28
Model NumberN/A
Catalog NumberUNKNOWN
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device Availability*
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 2019-08-28

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