UNKNOWN REMOTION WRIST CARPAL BALL IMPLANT 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 2019-03-08 for UNKNOWN REMOTION WRIST CARPAL BALL IMPLANT UNK_SEL manufactured by Stryker Gmbh.

Event Text Entries

[138271523] Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device disposition unknown.
Patient Sequence No: 1, Text Type: N, H10


[138271524] The manufacturer became aware of a study from private (b)(6). The title of this study is? What we know after a decade of total wrist prostheses? And is associated with the remotion total wrist system. Within that publication, post-operative complications/ adverse events were reported, which occurred between 2009 and 2015. It was not possible to ascertain specific device catalogs 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 30 complaints were initiated retrospectively for different adverse events mentioned in the report. This product inquiry addresses revision due to osteolysis. 3 out of 5 cases.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0008031020-2019-00173
MDR Report Key8404616
Report SourceHEALTH PROFESSIONAL
Date Received2019-03-08
Date of Report2019-03-08
Date of Event2009-01-01
Date Mfgr Received2019-02-26
Date Added to Maude2019-03-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. ROSE HAAS
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 REMOTION WRIST CARPAL BALL IMPLANT
Generic NameIMPLANT
Product CodeKWO
Date Received2019-03-08
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 2019-03-08

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