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U.S. Department of Health and Human Services

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

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STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR JTS - TIBIAL COMPONENT PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number UNK_STM
Device Problem Loss of Osseointegration (2408)
Patient Problems Pain (1994); Inadequate Osseointegration (2646)
Event Date 02/22/2022
Event Type  Injury  
Event Description
It has been reported "there is now this young girl (b)(6) with an aseptic loosening of the tibial component with pain".
 
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.
 
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Brand NameDISTAL FEMUR JTS - TIBIAL COMPONENT
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 Key13787201
MDR Text Key287538353
Report Number3004105610-2022-00030
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeFR
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
Report Date 03/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2020
Device Catalogue NumberUNK_STM
Device Lot NumberPIN 22232
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/26/2020
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: 03/16/2022 Patient Sequence Number: 1
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