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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN TIBIAL COMPONENT IMPLANT

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STRYKER GMBH UNKNOWN TIBIAL COMPONENT IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Injury (2348)
Event Date 01/01/2007
Event Type  Injury  
Manufacturer Narrative

This complaint has been reported during a literature review performed by the post market surveillance group. The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available. More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event. The device history record could not be reviewed because the affected lot number was not communicated. If any further information is provided, the investigation report will be updated. The reported device was manufactured and distributed by (b)(4) and implanted before stryker became the legal manufacturer. On april 1, 2015 stryker became the legal manufacturer of the star system and has taken the responsibility for the medical device reporting. Device disposition is unknown.

 
Event Description

The manufacturer became aware of a study from palo alto medical foundation, united states. The title of this report is ¿association of short-term complications with procedures through separate incisions during total ankle replacement¿ which is associated with the stryker ¿star prosthesis¿. Within that publication, post-operative complications/ adverse events were reported, which occurred from 2007 to 2013. It was not possible to ascertain specific device/patient details from the report, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 41 complaints were initiated retrospectively for adverse events mentioned in the report. This product inquiry addresses medial malleolar fracture treated with 2 partially treaded 4. 0-mm cancellous screws. 5 out of 6 cases. The report states: ¿the 6 malleolar fractures were treated with placement of 2 partially treaded 4. 0-mm cancellous screws parallel to each other and perpendicular to the fracture through a separate incision. ¿.

 
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Brand NameUNKNOWN TIBIAL COMPONENT
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
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9949615
MDR Text Key191983459
Report Number0008031020-2020-01241
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 04/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/10/2020
Is This An Adverse Event Report? Yes
Device Operator LAY USER/PATIENT
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 Received03/16/2020
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: 04/10/2020 Patient Sequence Number: 1
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