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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN TOTAL ANKLE PROSTHESIS IMPLANT

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STRYKER GMBH UNKNOWN TOTAL ANKLE PROSTHESIS IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 08/17/2021
Event Type  Injury  
Manufacturer Narrative
The device will not be returned. If additional information becomes available, it will be provided in a supplemental report. Device remains implanted.
 
Event Description
It was reported the patient had a total ankle revision. No further information has been provided.
 
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Brand NameUNKNOWN TOTAL ANKLE PROSTHESIS
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ 2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ 2545
Manufacturer Contact
kristen canter
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12450316
MDR Text Key270764714
Report Number0008031020-2021-00406
Device Sequence Number1
Product Code HSN
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
Report Date 09/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received08/18/2021
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: 09/09/2021 Patient Sequence Number: 1
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