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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN STAR TIBIAL COMPONENT; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

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STRYKER GMBH UNKNOWN STAR TIBIAL COMPONENT; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED Back to Search Results
Catalog Number UNK_SEL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Injury (2348)
Event Date 05/18/2015
Event Type  Injury  
Manufacturer Narrative
¿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 published by (b)(6), usa.The title of this report is ¿radiographic outcomes of a mobile-bearing total ankle replacement¿ which is associated with the stryker ¿scandinavian total ankle replacement (star)¿ system.The article can be found with pubmed id 25970784.Within that publication, post-operative complications/ adverse events were reported, which allegedly occurred from july 1998 to april 2007.It was not possible to ascertain specific device details or patient information from the report, or to match the events reported with previously reported complaints.Therefore, 23 complaints were initiated retrospectively for the post-operative complications mentioned in the report.This product inquiry addresses pseudomonas infection requiring explantation.The report states: ¿one of the excluded patients had an early postoperative pseudomonas infection requiring explantation¿.
 
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Brand Name
UNKNOWN STAR TIBIAL COMPONENT
Type of Device
PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
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 Key10152855
MDR Text Key195125520
Report Number0008031020-2020-01646
Device Sequence Number1
Product Code NTG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P050050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation Physician
Type of Report Initial
Report Date 06/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 05/19/2020
Initial Date FDA Received06/15/2020
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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