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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE LTD METS SMILES TOTAL KNEE REPLACEMENT; LIMB SALVAGE SYSTEM
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STANMORE IMPLANTS WORLDWIDE LTD METS SMILES TOTAL KNEE REPLACEMENT; LIMB SALVAGE SYSTEM Back to Search Results
Model Number CRC TKR 1547
Device Problems Device Reprocessing Problem (1091); Delivered as Unsterile Product (1421); Device Contamination with Body Fluid (2317)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/11/2015
Event Type  malfunction  
Manufacturer Narrative
The soiled instruments are under evaluation.The investigation is ongoing and the results will be provided in a supplemental report.
 
Event Description
It was reported by the customer that the instrumentation provided with the mets smiles total knee replacement had what appeared to be blood on it.Replacement tooling was sent to the customer by courier and the 'soiled' set was collected from them.There was no delay to the surgery.(b)(4).
 
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Brand Name
METS SMILES TOTAL KNEE REPLACEMENT
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
sharon allen-phillips
210 centennial avenue
centennial park, elstree
borehamwood, WD6 3-SJ
UK   WD6 3SJ
2082386500
MDR Report Key5285072
MDR Text Key33126347
Report Number3004105610-2015-00121
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K120992
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Type of Report Initial
Report Date 11/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCRC TKR 1547
Device Lot NumberSM T
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/11/2015
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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