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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR JTS - FEMORAL STEM PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR JTS - FEMORAL STEM PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number UNK_STM
Device Problem Osseointegration Problem (3003)
Patient Problems Injury (2348); Inadequate Osseointegration (2646); Cancer (3262)
Event Date 11/13/2019
Event Type  Injury  
Manufacturer Narrative
Reported event: an event regarding loosening of a femoral component involving a jts distal femur was identified during x-ray review. Method and results: product evaluation and results: not performed as no items were returned. Clinician review: the implant in situ was for a jts distal femoral replacement which was inserted in (b)(6) 2016. The surgeon reported the maximum extension of the implant. The ct scan provided showed that the implant has been extended by 90mm which has not reached to its maximum capacity of 110mm. Therefore, one more extension is required before the maximum extension. In addition, the radiolucent lines between the cement mantle and the bone along the femoral stem has been observed. Therefore, the radiographic assessment can confirm in part the clinical report. Product history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on 30nov2015 with no reported discrepancies. Complaint history review: based on the device identification the complaint databases were reviewed from 01jan2016 to present for similar reported events regarding loosening in femoral stem of jts distal femur. There have been 12 other events. Conclusions: an event regarding loosening of a femoral component involving a jts distal femur was identified during x-ray review. The exact cause of the event could not be determined because further information such as 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 siw. If devices and/or additional information become available to indicate further evaluation is warranted, this record will be re-opened. Device not returned.
 
Event Description
During the x-ray review to investigate muscle contracture (mfr ref #3 004105610-2019-00132) it was observed there was loosening of the femoral stem.
 
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Brand NameDISTAL FEMUR JTS - FEMORAL STEM
Type of DevicePROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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 Key9780463
MDR Text Key183738820
Report Number3004105610-2020-00042
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeRU
PMA/PMN Number
K133152
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial
Report Date 03/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_STM
Device Lot NumberPIN 19802
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 Received12/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2015
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: 03/03/2020 Patient Sequence Number: 1
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