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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE LOCKING JACKET EXTRACTION SCREW - SPECIAL PROXIMAL TIBIAL REPLACEMENT PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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STANMORE IMPLANTS WORLDWIDE LOCKING JACKET EXTRACTION SCREW - SPECIAL PROXIMAL TIBIAL REPLACEMENT PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number UNK_STM
Device Problem Break (1069)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/21/2020
Event Type  malfunction  
Manufacturer Narrative
The reported device is similar to a device approved for compassionate use in the united states. An investigation is being performed in an attempt to identify the cause of the event. Should additional information become available it will be reported in a supplemental report. Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. Device not returned.
 
Event Description
As reported: "the device from 22293 incorporates two surgical options for intraoperative flexibility; plan a and plan b. Plan a of the procedure failed when the 4mm extraction bolt snapped. The surgeon opted for plan b as planned. The inner piston in situ was cut in half as per the surgeon's initial intentions. The new device was slotted over the cut inner piston and secured in place before the wound was closed. A 10mm spacer was used in conjunction with the device. The surgeon was pleased with the outcome and mentioned the operation duration was quick. ".
 
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Brand NameLOCKING JACKET EXTRACTION SCREW - SPECIAL PROXIMAL TIBIAL REPLACEMENT
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 Key10153281
MDR Text Key195394001
Report Number3004105610-2020-00103
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeGB
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 10/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/17/2020
Device Catalogue NumberUNK_STM
Device Lot NumberPIN 22293
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/21/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/14/2020
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: 06/15/2020 Patient Sequence Number: 1
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