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U.S. Department of Health and Human Services

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

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STANMORE IMPLANTS WORLDWIDE UNKNOWN METS DISTAL FEMUR - STEM PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number UNK_STM
Device Problem Loss of Osseointegration (2408)
Patient Problems Unspecified Infection (1930); Inadequate Osseointegration (2646)
Event Date 12/01/2020
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. Catalog numbers and lot codes of other devices listed in this report: unknown mets collar, lot unknown; unknown mets knee with epiphysis, lot unknown; unknown mets tibial component, lot unknown; it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
 
Event Description
As reported: "i¿ve just been informed of this revision case, cause: sceptic loosening. The patient was operated in (b)(6) 2011. Dr. Needs to remove this prosthesis and implant another mets distal femur. He expressed that wants to remove the implant, and change the femur, with a wider and longer stem and shaft. Also change all polyethylene and rotatory pieces. He won¿t remove the tibial plateau. Operation date: (b)(6). ".
 
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Brand NameUNKNOWN METS DISTAL FEMUR - 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
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 Key11010663
MDR Text Key221492898
Report Number3004105610-2020-00196
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K121029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2021
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: 12/15/2020 Patient Sequence Number: 1
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