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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN REMOTION WRIST CARPAL BALL IMPLANT

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STRYKER GMBH UNKNOWN REMOTION WRIST CARPAL BALL IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Osteolysis (2377)
Event Date 01/01/2009
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided on a supplemental report. Device disposition unknown.
 
Event Description
The manufacturer became aware of a study from (b)(6). The title of this study is (b)(6) 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 lysis. 7 out of 22 cases.
 
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Brand NameUNKNOWN REMOTION WRIST CARPAL BALL IMPLANT
Type of DeviceIMPLANT
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
kevin smith
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8409544
MDR Text Key138445951
Report Number0008031020-2019-00219
Device Sequence Number0
Product Code JWJ
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 03/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue NumberUNK_SEL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2019
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 Treatment Data
Date Received: 03/11/2019 Patient Sequence Number: 1
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