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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN IVORY TITANIUM ALLOY CUP IMPLANT

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STRYKER GMBH UNKNOWN IVORY TITANIUM ALLOY CUP IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problem Loss of Osseointegration (2408)
Patient Problems Pain (1994); Injury (2348)
Event Date 07/17/2018
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 is unknown.
 
Event Description
The manufacturer became aware of a literature published by elda university hospital, in spain. The title of this report is ¿outcomes of cementless joint prosthesis versus tendon interposition for trapeziometacarpal osteoarthritis: a prospective study¿ which is associated with the stryker ¿ivory modular prosthesis¿ system. Article can be found on https://journals. Sagepub. Com/doi/10. 1177/1753193418787151. Within that publication which included 84 patients, post-operative complications were reported, which allegedly occurred between 2012 to 2015. It was not possible to ascertain specific device details or patient information from the report, or to match the events reported with previously reported complaints. Therefore, new complaints were initiated in the system for the post-operative complications mentioned in the report. This product inquiry addresses loosening of cup and pain followed by revision. The report states: ¿another patient, who presented with loosening of the cup and pain, was revised to a new prosthesis at 23 months after operation. ¿.
 
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Brand NameUNKNOWN IVORY TITANIUM ALLOY CUP
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
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10388607
MDR Text Key203155032
Report Number0008031020-2020-02115
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeES
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 08/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2020
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 Received07/14/2020
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: 08/10/2020 Patient Sequence Number: 1
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