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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN CARPAL IMPLANT

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STRYKER GMBH UNKNOWN CARPAL IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Loss of Range of Motion (2032)
Event Date 09/09/2020
Event Type  Injury  
Manufacturer Narrative
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. Device disposition unknown.
 
Event Description
The manufacturer became aware of a post market clinical follow-up report received from the (b)(6) center, in usa. The title of this report is ¿remotion total wrist arthroplasty: retrospective evaluation of outcomes during the first postoperative year¿ which is associated with the stryker ¿remotion total wrist system¿. This study includes research done on 21 patients requiring surgery between the period 2014 and 2019. It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints. Therefore, new complaint was initiated in the system for the post-operative complication mentioned in the report. This product inquiry addresses reduction of arc of active wrist flexion-extension from pre-operative (110) to post-operative (70).
 
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Brand NameUNKNOWN CARPAL IMPLANT
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ 2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ 2545
Manufacturer Contact
kevin smith
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10659179
MDR Text Key211028729
Report Number0008031020-2020-02309
Device Sequence Number1
Product Code JWJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Reporter Occupation
Type of Report Initial
Report Date 10/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_SEL
Device Lot NumberUNKNOWN
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 Received09/14/2020
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: 10/09/2020 Patient Sequence Number: 1
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