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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE PROXIMAL FEMUR JTS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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STANMORE IMPLANTS WORLDWIDE PROXIMAL FEMUR JTS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Catalog Number UNK_STM
Device Problem Mechanical Problem (1384)
Patient Problems Injury (2348); Cancer (3262)
Event Date 05/30/2019
Event Type  Injury  
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.Device remains implanted.
 
Event Description
It is reported that " unfortunately despite an hour of trying to get the gear to expand we were unable to see much change on x-ray and we aborted.Clinically his leg lengths appear similar to the way he has been so no change.We could feel the vibration in the leg but no expansion.The device hasn't been expanded in 5 years".
 
Event Description
It is reported that " unfortunately despite an hour of trying to get the gear to expand we were unable to see much change on x-ray and we aborted.Clinically his leg lengths appear similar to the way he has been so no change.We could feel the vibration in the leg but no expansion.The device hasn't been expanded in 5 years".
 
Manufacturer Narrative
Reported event: an event regarding seizing involving a patient specific jts proximal femur was reported.The event was not confirmed.Method and results: product evaluation and results: not performed as no device was returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the product history records indicate (b)(6) device was manufactured and accepted into final stock on 31aug2012 with no reported discrepancies.Complaint history review: based on the device identification the complaint databases were reviewed from 30may2016 to present for similar reported events regarding seizing of extension mechanism in a jts proximal femur.There have been no other events.Siw will continue to monitor for trends.Conclusions: an event regarding seizing involving a patient specific jts proximal femur was reported.The surgeon stated that the implant "hasn¿t been expanded in 5 years" and the senior staff engineer confirmed that "the gearbox laying dormant for 5 years may have contributed to the prosthesis not extending".The exact cause of the event could not be determined because further information such as pre- and post-operative x-rays and the primary operative report as well as patient history and follow up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by siw.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be re-opened.Siw will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.H3 other text: device not returned.
 
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Brand Name
PROXIMAL FEMUR JTS
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Manufacturer (Section D)
STANMORE IMPLANTS WORLDWIDE
210 centennial avenue
centennial park, elstree
borehamwood WD6 3 SJ
GB  WD6 3SJ
MDR Report Key8735321
MDR Text Key149216929
Report Number3004105610-2019-00079
Device Sequence Number1
Product Code JDI
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 08/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date08/31/2013
Device Catalogue NumberUNK_STM
Device Lot NumberPIN 17264
Was Device Available for Evaluation? No
Device Age6 YR
Initial Date Manufacturer Received 05/30/2019
Initial Date FDA Received06/26/2019
Supplement Dates Manufacturer Received08/27/2019
Supplement Dates FDA Received08/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MSFMH-CC28M0 (B9357) FEMORAL HEAD DIA 0.; MSFMH-CC28M3.5 (B8465) FEMORAL HEAD DIA-3.5.; MSFMH-CC28P10.5 (B9196) FEMORAL HEAD DIA +10.5.; MSFMH-CC28P3.5 (B9025) FEMORAL HEAD DIA +3.5.; MSFMH-CC28P7 (B9026) FEMORAL HEAD DIA +7.; MSFMH-CC2M0 (B8128) FEMORAL HEAD 22 DIA-0.; MSFMH-CC2P3 (B5485) FEMORAL HEAD 22 DIA+3.
Patient Outcome(s) Other;
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