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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN TALAR COMPONENT IMPLANT

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STRYKER GMBH UNKNOWN TALAR COMPONENT IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problems Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923)
Patient Problems Failure of Implant (1924); Injury (2348)
Event Date 11/01/2001
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 small bone innovation, inc. , (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 literature from st. Michael¿s hospital, canada. The title of this report is ¿intermediate to long-term outcomes of total ankle replacement with the scandinavian total ankle replacement (star)¿ which is associated with the stryker ¿scandinavian total ankle replacement (star)¿ system. Within that publication, post-operative complications/ adverse events were reported, which occurred from november 2001 to october 2005. It was not possible to ascertain specific device 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 64 complaints were initiated retrospectively for adverse events mentioned in the report. This product inquiry addresses talar loosening and subsidence followed by revision. The report states: ¿thirteen (12%) of the ankles required metal component revision. Seven of the ankles were converted to tibiotalocalcaneal arthrodesis.

 
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Brand NameUNKNOWN TALAR 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 Key9792661
MDR Text Key190938916
Report Number0008031020-2020-00583
Device Sequence Number1
Product Code HSN
Combination Product (Y/N)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 03/05/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/05/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem 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 Received02/11/2020
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: 03/05/2020 Patient Sequence Number: 1
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