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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.
 
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.
 
Manufacturer Narrative
An event regarding a size/fit issue involving a mets, distal femur, tibial component was reported.The event was confirmed by product inspection.Method & results: device evaluation and results: visual inspection: review of the tibial assembly (with the pre-assembled bumper pad) shows that each component is visually unremarkable with no evidence of misuse, shipping, handling, or storage damage.Dimensional and functional inspection comments: after decontamination, the tibial assembly was returned to stryker stanmore for assessment.Re-inspection of the assembly found the bumper pad to also be smaller in dimension, however the plastic component was reprocessed (heated & washed) when cleaned which can cause this difference.Re- inspection of the tibial component (lot number: b21461) confirmed that the distance between the dovetail features was oversized and out of specification.The dovetail feature retains the bumper pad in place when fully assembled.An oversized dovetail feature may lead to excessive clearance with the bumper pad and hence fail to retain the bumper pad in position before it is assembled with the femoral component.Clinician review: not performed as the alleged device was not implanted.Device history review: review of the product history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: based on the device identification the complaint databases were reviewed for similar events regarding a size/fit issue.Lot id: a21848.There have been no other events for the lot referenced.Conclusion: the investigation concluded that the size/fit issue was caused by the oversized dovetail feature of the tibial component, an oversized dovetail feature can cause excessive clearance with the corresponding bumper pad and could appear or feel loose or fail to retain the corresponding bumper pad.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.Corrective action/preventive action: on 09 february 2021 an nc was raised.
 
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Brand Name
TIB. CAS. ASSY STD SHORT STEM
Type of Device
PROSTHESIS, 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
MDR Report Key10434891
MDR Text Key204566469
Report Number3004105610-2020-00130
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
K121029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
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 Health Professional
Device Expiration Date07/31/2023
Device Catalogue NumberMKRHM-STDST
Device Lot NumberA21848
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2020
Date Manufacturer Received03/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age64 YR
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