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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE LTD METS DISTAL FEMUR REPLACEMENT IMPLANT; LIMB SALVAGE SYSTEM
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STANMORE IMPLANTS WORLDWIDE LTD METS DISTAL FEMUR REPLACEMENT IMPLANT; LIMB SALVAGE SYSTEM Back to Search Results
Device Problem Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/22/2014
Event Type  malfunction  
Event Description
The surgeon performed a mets distal femur replacement procedure on (b)(6) 2014.During the procedure, the surgeon reported that he was unable to insert the trial axle in the left tibial trial instrument.It was also reported that the surgeon expressed dissatisfaction with the company's instrumentation.In particular, he noted that the external tibial cutting guide instrumentation should be more precise in order to ensure a good cut.The procedure was successfully completed using a competitor's tibial cutting guide and reamers.The incident was reported to delay the procedure by approximately 30 minutes with no negative effects on the patient's well being.
 
Manufacturer Narrative
The reusable implant instrumentation kit was returned, inspected and refurbished per procedure.The trial hinge cylinder in particular was observed to show signs of wear preventing the axle being inserted.The trial hinge cylinder was refurbished, re-inspected and determined to be fit for use.The manufacturing records associated with the reusable trial hinge cylinder were reviewed and no non-conformances were identified.There have been no similar complaint reports related to the trial axle in the past 24 months.Investigation of this issue is ongoing; a supplemental report will be provided.The surgeon's comments regarding the reusable implant instrumentation have been forwarded to the company's design group for consideration.
 
Manufacturer Narrative
Mets distal femur trial component was returned on 06-nov-2014, device investigation identified burr on the inside of the fixed hinge cylinder preventing insertion of axle.Batch card was reviewed with no non-conformities identified.The trial hinge cylinder was refurbished, re-inspected and determined to be fit for use.The surgeon's comments regarding the reusable implant instrumentation have been forwarded to the company's design group (20-nov-2014) for consideration.
 
Event Description
The surgeon performed a mets distal femur replacement procedure on (b)(6) 2014.During the procedure, the surgeon reported that he was unable to insert the trial axle in the left tibial trial instrument.It was also reported that the surgeon expressed dissatisfaction with the company's instrumentation.In particular, he noted that the external tibial cutting guide instrumentation should be more precise in order to ensure a good cut.The procedure was successfully completed using a competitor's tibial cutting guide and reamers.The incident was reported to delay the procedure by approximately 30 minutes with no negative effects on the patient's well being.This is a supplemental report to 3004105610-2014-00050 ((b)(4)).
 
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Brand Name
METS DISTAL FEMUR REPLACEMENT IMPLANT
Type of Device
LIMB SALVAGE SYSTEM
Manufacturer (Section D)
STANMORE IMPLANTS WORLDWIDE LTD
210 centennial avenue
centennial park
elstree, 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 Key4290803
MDR Text Key5273114
Report Number3004105610-2014-00050
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K121029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,company representati
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/22/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/29/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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