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U.S. Department of Health and Human Services

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

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STRYKER GMBH UNKNOWN STAR POLYETHYLENE COMPONENT; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED Back to Search Results
Catalog Number UNK_SEL
Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Patient Problem Injury (2348)
Event Date 10/10/2006
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.
 
Event Description
The manufacturer became aware of a literature published by falu hospital, in sweden.The title of this report is ¿secondary surgery after total ankle replacement: the influence of preoperative hindfoot alignment¿ which is associated with the stryker ¿scandinavian total ankle replacement (star)¿ system.The article can be found at https://www.Sciencedirect.Com/science/article/pii/s1268773106000919.Within that publication, post-operative complications were mentioned, which allegedly occurred from 1997 to 2004.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, 12 complaints were initiated retrospectively for the post-operative complications mentioned in the report.This product inquiry addresses (4) cases of instability and worn out polyethylene bearing followed by revision, out of (109) patients.The report states: ¿the most frequent reasons for revision were instability with dislocation or subluxation of the polyethylene insert [¿] all cases revised because of instability showed considerable wear of the polyethylene component as a results from edge loading¿.
 
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Brand Name
UNKNOWN STAR POLYETHYLENE 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 Key10183872
MDR Text Key196085385
Report Number0008031020-2020-01731
Device Sequence Number1
Product Code NTG
Combination Product (y/n)N
Reporter Country CodeSE
PMA/PMN Number
P050050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 06/23/2020
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? 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
Initial Date Manufacturer Received 05/26/2020
Initial Date FDA Received06/23/2020
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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