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U.S. Department of Health and Human Services

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

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STANMORE IMPLANTS WORLDWIDE LTD DISTAL FEMUR PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Lot Number PIN 19960
Device Problem Device-Device Incompatibility (2919)
Patient Problem Cancer (3262)
Event Date 03/18/2016
Event Type  malfunction  
Manufacturer Narrative
Post-operative x-rays were provided to the stanmore implants design department. Based upon a review of these x-rays, it appears as though the tibial component which was supplied and implanted during this custom device procedure was an incorrect size. The investigation is ongoing. A supplemental report will be provided.
 
Event Description
During assembly of the tibial component, it appeared as though the metal hinge component sat high on the all-poly component, raising it a few millimeters. The component was implanted and the procedure was completed. Also, during the procedure and the following day, the surgeon shared his comments and preferences for the stanmore implants design office to consider in the design of future custom device cases.
 
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Brand NameDISTAL FEMUR
Type of DevicePROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
STANMORE IMPLANTS WORLDWIDE LTD
210 centennial avenue
centennial park
elstree, hertfordshire WD6 3 SJ
UK WD6 3SJ
Manufacturer Contact
diana rogers
210 centennial avenue
centennial park
elstree, hertfordshire WD6 3-SJ
UK   WD6 3SJ
MDR Report Key6420203
MDR Text Key240650031
Report Number3004105610-2016-00022
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140898
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 03/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2016
Device Lot NumberPIN 19960
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 Received03/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/08/2016
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: 03/21/2017 Patient Sequence Number: 1
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