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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN FEMUR NAIL BOLT IMPLANT

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STRYKER TRAUMA KIEL UNKNOWN FEMUR NAIL BOLT IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Injury (2348); Ambulation Difficulties (2544)
Event Date 07/01/2017
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report. Device disposition is unknown.
 
Event Description
It was reported through medwatch (mw5090330) "pt states shortly after stryker hip implant was put in for a fracture right femur bone. She started having issues with it. Pt thinks the bolt of the device was sticking out and causing her so much pain that she couldn't walk, sit or bend. Pt states for 10 months, she went through hell with the device in her. Finally got the device taken out in 2018. ".
 
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Brand NameUNKNOWN FEMUR NAIL BOLT
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
D-24232
Manufacturer Contact
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9372353
MDR Text Key178374306
Report Number0009610622-2019-00940
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/30/2019
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: 11/25/2019 Patient Sequence Number: 1
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