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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN STAR ANKLE POLY IMPLANT

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STRYKER GMBH UNKNOWN STAR ANKLE POLY IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Cyst(s) (1800)
Event Date 06/13/2019
Event Type  Injury  
Manufacturer Narrative
Per the event description, revision surgery is still pending. If the device is returned or if additional information becomes available, it will be provided in a supplemental report. Still implanted in patient at this time.
 
Event Description
Rep was notified by surgeon of a revision to take place (b)(6) 2019 of the patient's star ankle due to suspected mechanical failure of the poly. Cystic formation in the patient's tibia, talus, and calcaneus were also reported.
 
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Brand NameUNKNOWN STAR ANKLE POLY
Type of DeviceIMPLANT
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
kevin smith
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8767216
MDR Text Key150263184
Report Number0008031020-2019-00795
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_SEL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/08/2019 Patient Sequence Number: 1
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