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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE SMILES KNEE BUSHES SMALL PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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STANMORE IMPLANTS WORLDWIDE SMILES KNEE BUSHES SMALL PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number SMBSH01
Device Problem Naturally Worn (2988)
Patient Problem Pain (1994)
Event Date 10/07/2020
Event Type  Injury  
Manufacturer Narrative
Reported event: an event regarding rebushing involving a jts distal femur was reported. The event was confirmed by medical review. Method & results: product evaluation and results: not performed as no items were returned. Clinician review: the x-rays provided shows a slight tilt between the hinge component and tibial plateau. Considering the number of years in situ, this probably is a normal wear and tear of the knee bearing materials. Product history review: not performed as no lot number was provided. Complaint history review: not performed as no lot number was provided. Conclusions: an event regarding rebushing involving a jts distal femur was reported. The event was confirmed by medical review. The exact cause of the event could not be determined because further information such as x-rays taken post implantation and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause. No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics. If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened. Device not returned.
 
Event Description
The patient specific prescription form and complaint notification form indicate that the patient's right distal femur is being revised due to implant failure. It indicates that a new poly and new bearings are needed. The stem will stay in place, and a new axle and new femoral component will be needed to match the remaining stem and tibial component. The patient has pain in her knee and surgeon voiced concern that the implant may be bending. Update 09dec20 - it was reported in the x-ray review that "the x-rays provided shows a slight tilt between the hinge component and tibial plateau but the x-ray has limited view to show the rest of the tibial component. Considering the number of years that the implant is in situ, this probably is a normal wear and tear of the knee bearing materials. ".
 
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Brand NameSMILES KNEE BUSHES SMALL
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 Key11088848
MDR Text Key224115539
Report Number3004105610-2020-00202
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
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 12/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberSMBSH01
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 Received12/09/2020
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: 12/29/2020 Patient Sequence Number: 1
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