PERSONA CEMENTED STEMMED TIBIAL COMPONENT SIZE E RIGHT N/A 42532007102

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for PERSONA CEMENTED STEMMED TIBIAL COMPONENT SIZE E RIGHT N/A 42532007102 manufactured by Zimmer Orthopaedic Mfg. Ltd..

Event Text Entries

[188010169] (b)(4). Concomitant medical products: persona cruciate retaining cemented femoral component size 6 right, catalog #: 42502606002, lot #: 63863881. Persona cruciate retaining articular surface 11mm right, catalog #: 42521000511, lot #: 63226721. Report source - foreign: (b)(6). The complainant has indicated that the devices will not be returned to zimmer biomet for evaluation, as the devices remain implanted. Multiple mdr reports were filed for this patient; please see all reports associated with this event: 3007963827-2020-00096, 3007963827-2020-00098.
Patient Sequence No: 1, Text Type: N, H10


[188010170] It is reported that the patient experienced severe pain, swelling difficulty performing daily activities and noise from the knee approximately two (2) years following right knee arthroplasty. The patient is currently taking paracetamol for pain management. Attempts have been made and no additional information is available at this time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007963827-2020-00097
MDR Report Key9902933
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-16
Date Mfgr Received2020-03-22
Device Manufacturer Date2017-01-05
Date Added to Maude2020-03-31
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 ORTHOPAEDIC MFG. LTD.
Manufacturer StreetBUILDING NO 2 EAST PARK SHANNON INDUSTRIAL ESTATE
Manufacturer CitySHANNON, COUNTY CLARE
Manufacturer CountryEI
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NamePERSONA CEMENTED STEMMED TIBIAL COMPONENT SIZE E RIGHT
Generic NamePROSTHESIS, KNEE
Product CodeJWH
Date Received2020-03-31
Model NumberN/A
Catalog Number42532007102
Lot Number63549985
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER ORTHOPAEDIC MFG. LTD.
Manufacturer AddressBUILDING NO 2 EAST PARK SHANNON INDUSTRIAL ESTATE SHANNON, COUNTY CLARE EI


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-31

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