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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR JTS - AXLE; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR JTS - AXLE; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number UNK_STM
Device Problems Naturally Worn (2988); Insufficient Information (3190)
Patient Problem Pain (1994)
Event Date 10/07/2020
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Device not returned.
 
Event Description
The patient specific prescription form and complaint notification form indicate that the patient's right distal femur is being revised due to implant failure.It indicates that a new poly and new bearings are needed.The stem will stay in place, and a new axle and new femoral component will be needed to match the remaining stem and tibial component.The patient has pain in her knee and surgeon voiced concern that the implant may be bending.
 
Event Description
The patient specific prescription form and complaint notification form indicate that the patient's right distal femur is being revised due to implant failure.It indicates that a new poly and new bearings are needed.The stem will stay in place, and a new axle and new femoral component will be needed to match the remaining stem and tibial component.The patient has pain in her knee and surgeon voiced concern that the implant may be bending.Update 09dec20 - it was reported in the x-ray review that "the x-rays provided shows a slight tilt between the hinge component and tibial plateau but the x-ray has limited view to show the rest of the tibial component.Considering the number of years that the implant is in situ, this probably is a normal wear and tear of the knee bearing materials.".
 
Manufacturer Narrative
Additional manufacturer narrative reported event: an event regarding rebushing involving a jts distal femur was reported.The event was confirmed by medical review.Method & results: product evaluation and results: not performed as no items were returned.Clinician review: the x-rays provided shows a slight tilt between the hinge component and tibial plateau.Considering the number of years in situ, this probably is a normal wear and tear of the knee bearing materials.Product history review: 1 device was manufactured and accepted into final stock on 25oct2013 with no reported relevant discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusions: an event regarding rebushing involving a jts distal femur was reported.The event was confirmed by medical review.The exact cause of the event could not be determined because further information such as x-rays taken post implantation and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
 
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Brand Name
DISTAL FEMUR JTS - AXLE
Type of Device
PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
STANMORE IMPLANTS WORLDWIDE
210 centennial avenue
centennial park, elstree
borehamwood WD6 3 SJ
UK  WD6 3SJ
MDR Report Key10751635
MDR Text Key213629571
Report Number3004105610-2020-00173
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
K133152
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 12/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/30/2014
Device Catalogue NumberUNK_STM
Device Lot NumberPIN 18063
Was Device Available for Evaluation? No
Date Manufacturer Received12/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age23 YR
Patient Weight63
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