PARTIAL TIBIAL CEMENTED SIZE F LEFT MEDIAL N/A 42538000601

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-02-05 for PARTIAL TIBIAL CEMENTED SIZE F LEFT MEDIAL N/A 42538000601 manufactured by Zimmer Biomet, Inc..

Event Text Entries

[177828522] (b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Report source: event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[177828523] It was reported that approximately 1 month post implantation, the patient experienced pain and was found to have a tibial bone fracture. The patient has indicated a possible revision, but one has not been confirmed yet. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001825034-2020-00490
MDR Report Key9672279
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2020-02-05
Date of Report2020-03-10
Date of Event2020-01-07
Date Mfgr Received2020-03-09
Device Manufacturer Date2019-04-18
Date Added to Maude2020-02-05
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 ContactMS. CHRISTINA ARNT
Manufacturer Street56 E. BELL DR.
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1ZIMMER BIOMET, INC.
Manufacturer Street56 E. BELL DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal Code46582
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePARTIAL TIBIAL CEMENTED SIZE F LEFT MEDIAL
Generic NamePROSTHESIS, KNEE
Product CodeHSX
Date Received2020-02-05
Model NumberN/A
Catalog Number42538000601
Lot Number64271273
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER BIOMET, INC.
Manufacturer Address56 E. BELL DRIVE WARSAW IN 46582 US 46582


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-05

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