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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE JTS PROXIMAL FEMUR (REVISION OF PROXIMAL COMPONENTS) LIMB SALVAGE SYSTEM

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STANMORE IMPLANTS WORLDWIDE JTS PROXIMAL FEMUR (REVISION OF PROXIMAL COMPONENTS) LIMB SALVAGE SYSTEM Back to Search Results
Model Number PIN 21882
Device Problem Device-Device Incompatibility (2919)
Patient Problems Injury (2348); Cancer (3262)
Event Date 04/03/2019
Event Type  Injury  
Manufacturer Narrative
An investigation is being performed in an attempt to identify the cause of the event. Should additional information become available it will be reported in a supplemental report.
 
Event Description
At approximately 15:10, on (b)(6) 2019, it was reported by (b)(6) by a phone call to the siw design office, that the surgeon mr (b)(6) was having difficulty inserting the jts revision prosthesis (pin21882). Mr (b)(6) requested the attendance of a design engineer in surgery to troubleshoot why the device was not fitting as intended. (b)(6) went to theatres in (b)(6) as requested and (b)(6) entered theatre 7. The device was confirmed to not fit as intended. The surgeon reinserted the original proximal component and scribed a line on the end of the shaft to annotate the femoral neck angle. He removed this component and inserted the revision component and scribed the neck angle. The discrepancy between the two scribed lines was approximately 90 degrees. On discussion, the surgeon decided to leave the distal femoral component of the jts in situ as the patient still had a leg length discrepancy. On further discussion, the surgeon decided to retain the original proximal component as a spacer scaffold onto which a mets trochanter was cemented allowing the surgeon to close the patient with a view to revising at a later date. The pin numbers being revised were bme(pin)12560 and bme(pin)13138. There was a surgical delay of 30-60 minutes.
 
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Brand NameJTS PROXIMAL FEMUR (REVISION OF PROXIMAL COMPONENTS)
Type of DeviceLIMB SALVAGE SYSTEM
Manufacturer (Section D)
STANMORE IMPLANTS WORLDWIDE
210 centennial avenue
centennial park, elstree
borehamwood WD6 3 SJ
GB WD6 3SJ
Manufacturer (Section G)
STANMORE IMPLANTS WORLDWIDE
210 centennial avenue
centennial park, elstree
borehamwood WD6 3 SJ
GB WD6 3SJ
Manufacturer Contact
diana rogers
210 centennial avenue
centennial park, elstree
borehamwood WD6 3-SJ
GB   WD6 3SJ
2082386500
MDR Report Key8499887
MDR Text Key141477353
Report Number3004105610-2019-00046
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K092138
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2019
Device Model NumberPIN 21882
Device Catalogue NumberUNK_STM
Device Lot NumberPIN 21882
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/28/2019
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: 04/10/2019 Patient Sequence Number: 1
Treatment
PIN 12560 JTS MIDSHAFT FEMUR; PIN 13138 EXTENSION SHAFT FOR JTS MIDSHAFT FEMUR
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