TIBIAL COMPONENT PRECOAT RIGHT MEDIAL/LEFT LATERAL SIZE 4 N/A 00584200402

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-23 for TIBIAL COMPONENT PRECOAT RIGHT MEDIAL/LEFT LATERAL SIZE 4 N/A 00584200402 manufactured by Zimmer Biomet, Inc..

Event Text Entries

[185976197] (b)(4). Concomitant medical products: item#:00584201502; femoral component high flex precoat lot#: 61975145. Item#:00584202409; articular surface size 4 9 mm height lot#: unknown. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-01035. 0001822565-2020-01033.
Patient Sequence No: 1, Text Type: N, H10


[185976198] It was reported by patients legal counsel the patient underwent a right unicompartmental knee arthroplasty and was revised approximately 7 years later due to pain, radiolucency, femoral component fracture, loosening, and osteolysis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001822565-2020-01034
MDR Report Key9865513
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2020-03-23
Date of Report2020-03-23
Date of Event2019-04-01
Date Mfgr Received2020-02-28
Device Manufacturer Date2011-08-22
Date Added to Maude2020-03-23
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
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameTIBIAL COMPONENT PRECOAT RIGHT MEDIAL/LEFT LATERAL SIZE 4
Generic NamePROSTHESIS, KNEE
Product CodeHSX
Date Received2020-03-23
Model NumberN/A
Catalog Number00584200402
Lot Number61859767
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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. Hospitalization; 2. Required No Informationntervention 2020-03-23

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