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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN POLYETHYLENE COMPONENT IMPLANT

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STRYKER GMBH UNKNOWN POLYETHYLENE COMPONENT IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problem Fracture
Event Date 01/01/1999
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 literature from (b)(6) college of medicine, united states. The title of this report is ¿intermediate-term experience with the star total ankle in the united states¿ 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 january 1999 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 76 complaints were initiated retrospectively for adverse events mentioned in the report. This product inquiry addresses polyethylene fracture followed by its exchange. 4 out of 10 cases the report states: ¿nine ankles (6. 5%) required 10 polyethylene exchanges for component fracture at an average 8. 9± 3. 3 years post operation. One of these patients sustained 2 of these fractures, requiring polyethylene exchange. All polyethylene component fractures presented after an acute episode of pain following a fall, and none of these patients went on to tibial or talar component failure. ¿.

 
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Brand NameUNKNOWN POLYETHYLENE 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 Key9910163
Report Number0008031020-2020-00962
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 04/01/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/01/2020
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 Received03/09/2020
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: 04/01/2020 Patient Sequence Number: 1
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