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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN MOOVIS METACARPAL STEM; IMPLANT

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STRYKER GMBH UNKNOWN MOOVIS METACARPAL STEM; IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Neuropathy (1983); Pain (1994)
Event Date 01/01/2013
Event Type  Injury  
Manufacturer Narrative
This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible.Based on the investigation results, no definitive relation could be established between the product and the reported failure adverse consequence.The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information will be provided.If further relevant information becomes available, the investigation will be reevaluated and resubmitted accordingly.Device disposition is unknown.
 
Event Description
The manufacturer became aware of a post-market clinical follow-up (pmcf) from (b)(6).The title of this report is ¿prospective and a retrospective evaluation of the mid- to long-term outcomes of subjects treated with the moovistm prosthesis¿ which is associated with the stryker moovis prosthesis.Within that publication, post- operative complications/ adverse events were reported which occurred between 2013 and 2016.It was not possible to ascertain specific device catalog or patient information 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 9 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses neurodystrophy.1 out of 4 cases.The pmcf report states, ¿4 patients were diagnosed with neurodystrophy in post op, exhibiting moderate forms of this chronic pain syndrome.All the involved patients recovered from this neurodystrophty without significant sequelae.¿.
 
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Brand Name
UNKNOWN MOOVIS METACARPAL STEM
Type of Device
IMPLANT
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
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8925857
MDR Text Key156268906
Report Number0008031020-2019-01137
Device Sequence Number1
Product Code KXE
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 Physician
Type of Report Initial
Report Date 08/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue NumberUNK_SEL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/01/2019
Initial Date FDA Received08/23/2019
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 Sequence Number1
Patient Outcome(s) Other;
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