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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH TALAR COMP,SINGLE COATED US VERS SMALL, LEFT; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

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STRYKER GMBH TALAR COMP,SINGLE COATED US VERS SMALL, LEFT; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED Back to Search Results
Catalog Number 400255
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative
The reported device was manufactured and distributed by small bone innovation, inc., (b)(4).Stryker corporation purchased this product line on april 1, 2015 and will take the responsibility for medical device reporting.Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device remains implanted.
 
Event Description
Subject received a star in the left ankle on (b)(6) 2016.Subject presented with erythema around the star incision site on (b)(6) 2016 and was prescribed antibiotics and instructed to watch the area.Subject was admitted to the hospital on (b)(6) 2016 with a wound infection brought on by an allergic reaction from the topical antibiotic ointment or the vaseline gauze (reported by pi).I/d on (b)(6) 2016 revealed pseudomonas aeruginosa.The subject was treated in the hospital with iv antibiotic and discharged on (b)(6) 2016.Subject was instructed to take antibiotic by picc line at home and to return to the office for follow-up on (b)(6) 2016.
 
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Brand Name
TALAR COMP,SINGLE COATED US VERS SMALL, LEFT
Type of Device
PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH   2545
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6231171
MDR Text Key198581218
Report Number0008031020-2017-00011
Device Sequence Number1
Product Code NTG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P050050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date12/31/2019
Device Catalogue Number400255
Device Lot Number1441040
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/22/2020
Initial Date FDA Received01/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/05/2014
Is the Device Single Use? Yes
Type of Device Usage A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age75 YR
Patient SexMale
Patient Weight98 KG
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