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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE UNKNOWN METS DISTAL FEMUR PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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STANMORE IMPLANTS WORLDWIDE UNKNOWN METS DISTAL FEMUR PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number UNK_STM
Device Problem Insufficient Information (3190)
Patient Problem Pain (1994)
Event Date 05/18/2021
Event Type  Injury  
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.
 
Event Description
In elsevier's the knee journal issue 31 (2021) 97-109, distal femoral replacement - does length matter? mid-term results for distal femoral replacements (a study of 90 patients was reviewed. As per demographics provided, 43 patients were subject to revision arthroplasty and the remaining 47 patients reflect tumor surgery. Patient genders are listed as 47 males and 43 females, median age 71 for patient's subject to revision arthroplasty, all of whom had a stanmore distal femoral mets implanted between 2002 and 2019):, it was reported that 6 patients experienced pain as a complication after implantation of a stanmore mets distal femoral replacement. 3 patients were reported to have "thigh pain when mobile", and 3 patients were reported to have "knee pain. ".
 
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Brand NameUNKNOWN METS DISTAL FEMUR
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 Key13962086
MDR Text Key288290254
Report Number3004105610-2022-00039
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K121029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial
Report Date 03/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_STM
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received03/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/31/2022 Patient Sequence Number: 1
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