UNKNOWN TIBIAL COMPONENT UNK_SEL

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 2020-03-23 for UNKNOWN TIBIAL COMPONENT UNK_SEL manufactured by Stryker Gmbh.

Event Text Entries

[184478069] 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


[184478070] The manufacturer became aware of a literature from (b)(6). The title of this report is? A prospective study of four total ankle arthroplasty implants by non-designer investigators? Which is associated with the stryker? Star? System. Within that publication, post-operative complications/ adverse events were reported, which occurred from november 2001 to august 2010. 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 54 complaints were initiated retrospectively for adverse events mentioned in the report. This product inquiry addresses implant failure leading to revision of metal components for malposition. 4 out of 6 cases.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0008031020-2020-00799
MDR Report Key9865269
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-23
Date of Report2020-03-23
Date of Event2001-11-01
Date Mfgr Received2020-02-26
Date Added to Maude2020-03-23
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 StreetBOHNACKERWEG 1 POSTFACH
Manufacturer CitySELZACH 2545
Manufacturer CountryCH
Manufacturer Postal Code2545
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN TIBIAL COMPONENT
Generic NameIMPLANT
Product CodeNTG
Date Received2020-03-23
Catalog NumberUNK_SEL
Lot NumberUNKNOWN
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER GMBH
Manufacturer AddressBOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-23

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