LPS DISTAL FEM COMP XXSM RT 198714111

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-10-11 for LPS DISTAL FEM COMP XXSM RT 198714111 manufactured by Depuy Orthopaedics Inc Us.

Event Text Entries

[162014627] Product complaint: (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10


[162014628] The patient was revised to address infection. Implants were taken out. Press fit components implanted. No instruments broken. No post op and xrays available. Doi: unknown. Dor: (b)(6) 2019. Right knee.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2019-109403
MDR Report Key9180314
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-10-11
Date of Report2019-09-21
Date of Event2019-09-21
Date Mfgr Received2019-11-12
Device Manufacturer Date2018-11-06
Date Added to Maude2019-10-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone6107428552
Manufacturer G1DEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Street700 ORTHOPAEDIC DR.
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal Code465810988
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLPS DISTAL FEM COMP XXSM RT
Generic NameLPS AND S-ROM : KNEE FEMORAL
Product CodeKWH
Date Received2019-10-11
Catalog Number198714111
Lot NumberJ1421T
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS INC US
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-10-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.