METHA ?CAP 12/14 130?/0? SIZE 2 NC272T

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 2017-05-23 for METHA ?CAP 12/14 130?/0? SIZE 2 NC272T manufactured by Aesculap Implant Systems.

Event Text Entries

[75774594] (b)(4). Manufacturing site evaluation: evaluation on-going. Device not returned.
Patient Sequence No: 1, Text Type: N, H10


[75774595] Country of complaint: (b)(6). It was reported that about 5 years later, the patient has a problem with osteolysis so there is loosening on both sides of the knee. No revision surgery has been scheduled. All med watch submissions related to this report are: 9610612-2017-00293; 9610612-2017-00294.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2017-00294
MDR Report Key6585280
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2017-05-23
Date of Report2017-08-02
Date of Event2017-01-21
Date Facility Aware2017-05-18
Date Mfgr Received2017-01-21
Date Added to Maude2017-05-23
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. NICOLE BROYLES
Manufacturer Street615 LAMBERT POINTE DRIVE
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3145515988
Manufacturer G1AESCULAP AG
Manufacturer StreetPO BOX 40
Manufacturer CityTUTTLINGEN, 78501
Manufacturer CountryGM
Manufacturer Postal Code78501
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMETHA ?CAP 12/14 130?/0? SIZE 2
Generic NameIMPLANTS METHA
Product CodeHSA
Date Received2017-05-23
Model NumberNC272T
Catalog NumberNC272T
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP IMPLANT SYSTEMS
Manufacturer AddressPO BOX 40 TUTTLINGEN, 78501 GM 78501


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-05-23

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