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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.".
 
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.".
 
Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible however; x-ray images were provided which confirms screw breakage from the shaft.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.More detailed information about the complaint event, patient¿s medical records, x-rays 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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
 
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Brand Name
UNKNOWN FEMUR NAIL BOLT
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
DE  D-24232
MDR Report Key9372353
MDR Text Key178374306
Report Number0009610622-2019-00940
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
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 Lay User/Patient
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received12/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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