MCK TIBIAL BASEPLATE-LM/RL-SZ 3 180603

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-25 for MCK TIBIAL BASEPLATE-LM/RL-SZ 3 180603 manufactured by Mako Surgical Corp..

Event Text Entries

[186147956] Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies. There have been no other events for the lot referenced. It was noted that the device is not available for evaluation. If additional information is received, it will be provided in a supplemental report upon completion of the investigation. Device not returned.
Patient Sequence No: 1, Text Type: N, H10


[186147957] It was reported that the patient's left knee was revised due to loosening (it was not reported to the rep which device(s) experienced loosening. No possible cause or contributor for loosening was reported to the rep). The patient's mako pka was revised to a total cr knee. Rep provided explant pictures, primary and revision usage sheets, and reported that no further information will be released by the hospital or surgeon.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005985723-2020-00177
MDR Report Key9876917
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-25
Date of Report2020-03-25
Date of Event2020-02-26
Date Mfgr Received2020-02-26
Device Manufacturer Date2017-05-12
Date Added to Maude2020-03-25
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. ALESSANDRA CHAVEZ
Manufacturer Street2555 DAVIE ROAD
Manufacturer CityFORT LAUDERDALE FL 33317
Manufacturer CountryUS
Manufacturer Postal33317
Manufacturer Phone9546280700
Manufacturer G1MAKO SURGICAL CORP.
Manufacturer Street2555 DAVIE ROAD
Manufacturer CityFORT LAUDERDALE FL 33317
Manufacturer CountryUS
Manufacturer Postal Code33317
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMCK TIBIAL BASEPLATE-LM/RL-SZ 3
Generic NamePROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
Product CodeNPJ
Date Received2020-03-25
Model Number180603
Catalog Number180603
Lot Number26031116-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMAKO SURGICAL CORP.
Manufacturer Address2555 DAVIE ROAD FORT LAUDERDALE FL 33317 US 33317


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-25

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