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U.S. Department of Health and Human Services

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

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STRYKER GMBH UNKNOWN REMOTION WRIST CARPAL SCREW 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
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided. This complaint has been reported during a literature review performed by the post market surveillance group. No product identification is possible. 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. A review of the labeling did not indicate any abnormalities. As per ifu: contraindications bone, musculature, tendons, or adjacent soft tissue compromised by disease, infection, or prior implantation, which cannot provide adequate support or fixation for the prosthesis. Known sensitivity to materials used in this device. Strenuous loading, excessive mobility, and articular instability all may lead to accelerated wear and eventual failure by loosening, fracture, or dislocation of the device. Patients should be made aware of the increased potential for device failure when excessive demands are made upon it. Reuse of instruments designated as single use has been associated with necrosis of bone leading to implant failure. Also, as per ifu some of the adverse events are: there have been some reports of patients with metal sensitivity reactions following joint replacement. Implantation of materials such as cobalt chrome and/or titanium may result in foreign body reaction adjacent to the implant site. Injury to the surrounding nerves, blood vessels, tendons, or soft tissues can occur as a consequence of implanting this device. If the device is returned or if any additional information is provided, the investigation will be reassessed.
 
Event Description
The manufacturer became aware of a study from private hospital (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 lysis. 3 out of 22 cases.
 
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Brand NameUNKNOWN REMOTION WRIST CARPAL SCREW 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 Key8727016
MDR Text Key149061497
Report Number0008031020-2019-00696
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 06/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2019
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 Received05/29/2019
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: 06/24/2019 Patient Sequence Number: 1
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