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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE TIB. CAS. ASSY STD SHORT STEM PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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STANMORE IMPLANTS WORLDWIDE TIB. CAS. ASSY STD SHORT STEM PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number MKRHM-STDST
Device Problem Use of Device Problem (1670)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/24/2020
Event Type  malfunction  
Manufacturer Narrative
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. There have been no other similar events for the lot referenced.
 
Event Description
As reported by rep: "the surgeon opened a mets rotating hinge metal cased tibia and the bumper pad was disengaged from the rotating component and loose in the packaging. We were able to push it back in place however it was easily dislodged so not suitable for implantation. We had to open another implant instead. " surgical delay of approximately 10 minutes.
 
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Brand NameTIB. CAS. ASSY STD SHORT STEM
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 Key10434891
MDR Text Key204566469
Report Number3004105610-2020-00130
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K121029
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 03/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMKRHM-STDST
Device Lot NumberA21848
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/20/2018
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: 08/20/2020 Patient Sequence Number: 1
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