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U.S. Department of Health and Human Services

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

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STRYKER GMBH UNKNOWN REMOTION WRIST CARPAL IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problem Material Disintegration (1177)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 lyses. 21 out of 22 cases.
 
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Brand NameUNKNOWN REMOTION WRIST CARPAL 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 Key8415717
MDR Text Key138646966
Report Number0008031020-2019-00269
Device Sequence Number1
Product Code JWJ
Combination Product (y/n)N
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 03/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2019
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: 03/13/2019 Patient Sequence Number: 1
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