MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for UNKNOWN TALAR COMPONENT UNK_SEL manufactured by Stryker Gmbh.

Event Text Entries

[185900220] 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 (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.
Patient Sequence No: 1, Text Type: N, H10

[185900221] The manufacturer became aware of a literature from (b)(6), 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 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 coronal plane failure followed by below knee amputation. The report states:? The most common failure mode was progressive coronal plane deformity (n=8, 38%); however, no initial postoperative radiographs demonstrated coronal plan deformity greater than 4 degrees, and no threshold for tolerance of postoperative deformity was able to be determined. [? ] only 1 failure was acutely managed with below-knee amputation (bka); however, this was performed at an outside institution and it is unclear why this procedure was chosen or if it was necessary.?
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number0008031020-2020-00914
MDR Report Key9908211
Date Received2020-03-31
Date of Report2020-03-31
Date of Event1999-01-01
Date Mfgr Received2020-03-09
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. ANNA JUSINSKI
Manufacturer Street325 CORPORATE DRIVE
Manufacturer CityMAHWAH NJ 07430
Manufacturer CountryUS
Manufacturer Postal07430
Manufacturer Phone2018315000
Manufacturer G1STRYKER GMBH
Manufacturer CitySELZACH 2545
Manufacturer CountryCH
Manufacturer Postal Code2545
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameIMPLANT
Product CodeHSB
Date Received2020-03-31
Catalog NumberUNK_SEL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER GMBH
Manufacturer AddressBOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545


Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Deathisabilit 2020-03-31

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