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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH (MDR) UNKNOWN_SELZACH_PRODUCT IMPLANT

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STRYKER GMBH (MDR) UNKNOWN_SELZACH_PRODUCT IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 05/05/2015
Event Type  Injury  
Event Description

It was reported that a revision of a star total ankle has been scheduled for soft tissue replacement. Routine polyethylene exchange is anticipated.

 
Manufacturer Narrative

The reported device was manufactured and distributed by small bone innovation, inc. , (b)(4) and implanted prior to howmedica osteonics corp. ¿s purchase of certain assets of sbi on (b)(6) 2014. Stryker became legal manufacturer of this product on (b)(6) 2015 and has taken the responsibility for medical device reporting. Unknown star polyethylene. Once the investigation has been completed any additional information will be reported in a supplemental report.

 
Manufacturer Narrative

Please note corrections: evaluation summary: according to information provided by stryker sales rep. The surgery had been rescheduled for (b)(6). Further information is expected to become available then. At the moment a revision surgery for soft tissue replacement is announced and a causal connection with the subject device ¿star polyethylene¿ is unclear. Furthermore a routine polyethylene exchange is anticipated but not actually scheduled. With respect to very sparse information a thorough investigation is not possible at the moment. The investigation thus will be closed formally and can be reopened as soon as further information is available.

 
Event Description

It was reported that a revision of a star total ankle has been scheduled for soft tissue replacement. Routine polyethylene exchange is anticipated.

 
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Brand NameUNKNOWN_SELZACH_PRODUCT
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER GMBH (MDR)
bohnackerweg 1
postfach
selzach 02545
SZ 02545
Manufacturer (Section G)
STRYKER GMBH (MDR)
bohnackerweg 1
postfach
selzach 02545
SZ 02545
Manufacturer Contact
rose haas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4814380
MDR Text Key5892486
Report Number0008031020-2015-00221
Device Sequence Number1
Product Code HTY
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/05/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/03/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device Catalogue NumberUNK_SEL
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2015
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: 06/03/2015 Patient Sequence Number: 1
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