UNKNOWN KNEE FEMORAL ADAPTOR BOLT UNK KNEE FEMORAL ADAPTOR BOLT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-02-21 for UNKNOWN KNEE FEMORAL ADAPTOR BOLT UNK KNEE FEMORAL ADAPTOR BOLT manufactured by Depuy Orthopaedics Inc Us.

Event Text Entries

[188690367] (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[188690368] The literature article entitled? Metaphyseal sleeves in revision total knee arthroplasty: minimum seven-year follow-up study? , written by sanjeev agarwal, et al. Published in the knee 25 (2018) 1299-1307, https://doi. Org/10. 1016/j. Knee. 2018. 09. 010, was reviewed. The purpose of the article was to report early results with the use of metal, porous coated metaphyseal sleeves in revision knee replacements. The authors present seven years of follow-up of the initial cohort. This is, as of yet, the longest follow-up report in literature. Products used: pfc & tc3, depuy index revision indications (figure 1): - aseptic loosening -infection -stiffness (four of these patients were revised to a noiles, depuy and underwent manipulations under anesthesia with continued restricted flexion); one patient was in her mid-40? S during index revision and had two further re-revisions for stiffness (these will be combined together due to insufficient information regarding the revisions), developed late infection four years after third revision and recently, in her mid-50? S opted for a two-stage arthrodesis-it is reasonable to conclude that this late infection four years after the last revision was not related to the implant -pain -instability re-revision indications (figure 1): -aseptic loosening (one patient revised for loosening had disengagement at the stem sleeve junction secondary to a technical error of tight fit of stem in femoral diaphysis) - infection (two-stage procedure, transfemoral amputation, distal femoral replacement prosthesis used for reconstruction, antibiotic suppression therapy) -persistent pain -instability other notes: figure 3 reports migration of the tibial component (radiographic images) table 1 shows degree of bone loss in femur and tibia. The discussion section mentions multiple further procedures including amputation. The article does not discuss patellar resurfacing or cement manufacturer.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-05638
MDR Report Key9739223
Report SourceFOREIGN,HEALTH PROFESSIONAL,L
Date Received2020-02-21
Date of Report2020-02-10
Date Mfgr Received2020-03-02
Date Added to Maude2020-02-21
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 DR
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone6107428552
Manufacturer G1JTE WARSAW MFG SITE
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal Code46582
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN KNEE FEMORAL ADAPTOR BOLT
Generic NameKNEE FEMORAL ADAPTOR BOLT
Product CodeHTN
Date Received2020-02-21
Catalog NumberUNK KNEE FEMORAL ADAPTOR BOLT
Lot NumberNA
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 2020-02-21

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