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U.S. Department of Health and Human Services

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

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STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR JTS - EXTENSION MECHANISM PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number UNK_STM
Device Problem Failure to Advance (2524)
Patient Problems Unequal Limb Length (4534); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2022
Event Type  malfunction  
Manufacturer Narrative
It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been no other similar events for the lot referenced. Device not returned.
 
Event Description
It has been reported there are issues lengthening the patient's distal femur jts. As reported: we repeated lengthening procedures 11 times (booster 3, driver a, 30 minutes time). We obtained initial lengthening of 36mm, but since 1 year, the lengthening is stopped despite the lengthening procedures. However, the theoretical lengthening was until 65mm.
 
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Brand NameDISTAL FEMUR JTS - EXTENSION MECHANISM
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
UK WD6 3SJ
Manufacturer (Section G)
STANMORE IMPLANTS WORLDWIDE
210 centennial avenue
centennial park, elstree
borehamwood WD6 3 SJ
UK WD6 3SJ
Manufacturer Contact
diana rogers
210 centennial avenue
centennial park, elstree
borehamwood WD6 3-SJ
UK   WD6 3SJ
2082386500
MDR Report Key13497571
MDR Text Key289221721
Report Number3004105610-2022-00015
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K133152
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Catalogue NumberUNK_STM
Device Lot NumberPIN 22249
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/20/2020
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: 02/09/2022 Patient Sequence Number: 1
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