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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN STAR TALAR COMPONENT IMPLANT

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STRYKER GMBH UNKNOWN STAR TALAR COMPONENT IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problem Loss of Osseointegration
Event Date 01/01/1993
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. Device disposition is unknown.

 
Event Description

The manufacturer became aware of a study from (b)(6) hospital, (b)(6). The title of this report is 'survival analysis of the single- and double-coated star ankle up to 20 years: long-term follow-up of 324 cases from the swedish ankle registry' which is associated with the stryker star prosthesis. Within that publication, postoperative complications/ adverse events were reported which occurred between 1993 and 2007. It was not possible to ascertain specific device or patient details from the study, 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 147 complaints was initiated retrospectively for adverse event mentioned in the study. This product inquiry addresses revision due to aseptic loosening. 57 out of 62 cases.

 
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Brand NameUNKNOWN STAR 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 Key9527256
Report Number0008031020-2019-02491
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 12/27/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/27/2019
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2019
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: 12/27/2019 Patient Sequence Number: 1
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