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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE PROXIMAL TIBIA JTS - AXLE; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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STANMORE IMPLANTS WORLDWIDE PROXIMAL TIBIA JTS - AXLE; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number UNK_STM
Device Problem Component Missing (2306)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2021
Event Type  malfunction  
Manufacturer Narrative
Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not sent.
 
Event Description
Rep attended the surgery and noticed that the axle was missing from the shipment.He alerted the surgeon to the situation and they were able to successfully complete the surgery by using a stryker axle in place of the missing stanmore axle.It has been further reported "the case was delayed by about an hour".
 
Manufacturer Narrative
Reported event: an event regarding missing component involving a jts, proximal tibia replacement, axle was reported.The event was not confirmed.Method & results: visual inspection: visual inspection of the provided picture of pin (b)(6) shows the implant and custom instrumentation is sealed and labelled.The label of the purple box has a tear, inside the box the components appear stacked and neatly organised on top a bed of foam.The boxed components appear intact and show no signs of tampering.The axle does not appear in any of the pictures provided, however no picture provided shows the entire contents of the purple box separated out.Clinician review: no medical records were received for review with a clinical consultant.Device history review: review of the product history records indicate the devices was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusion: consultation and discussion: the inspection lead from the operations quality team confirmed that all documentation indicates the device was dispatched.The sales rep confirmed the surgery occurred on (b)(6) 2021, it was also confirmed the implant packaging was sealed with tape on arrival.The packaging was opened by the charge nurse who thoroughly searched but could not find the axle in the box.However, after opening the box, the components list was not crosschecked against the contents of the box.It was reported that the surgery was successfully completed by using a stryker axle in place of the missing stanmore axle.The solution devised caused a 1 hour delay.The exact cause of the event could not be determined because insufficient information was provided.Additional information is needed to fully investigate the event.If further information becomes available this investigation will be re-opened.
 
Event Description
Rep attended the surgery and noticed that the axle was missing from the shipment.He alerted the surgeon to the situation and they were able to successfully complete the surgery by using a stryker axle in place of the missing stanmore axle.It has been further reported "the case was delayed by about an hour".Update 11 june 2021: the sales rep confirmed it was actually the charge nurse who noticed the axle missing from the shipment.
 
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Brand Name
PROXIMAL TIBIA JTS - AXLE
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 Key12023283
MDR Text Key264541859
Report Number3004105610-2021-00091
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
K092138
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK_STM
Device Lot NumberB31108
Was Device Available for Evaluation? No
Date Manufacturer Received08/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age9 YR
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