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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR JTS - EXTENSION MECHANISM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR JTS - EXTENSION MECHANISM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number UNK_STM
Device Problem Failure to Advance (2524)
Patient Problems Unequal Limb Length (4534); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2022
Event Type  malfunction  
Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation 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.Device not returned.
 
Event Description
It has been reported there are issues lengthening the patient's distal femur jts.As reported: we repeated lengthening procedures 11 times (booster 3, driver a, 30 minutes time).We obtained initial lengthening of 36mm, but since 1 year, the lengthening is stopped despite the lengthening procedures.However, the theoretical lengthening was until 65mm.
 
Manufacturer Narrative
Reported event: an event regarding seizing involving a jts, distal femoral replacement, extension mechanism was reported.The event was confirmed by x ray review.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: the implant in situ was for jts distal femoral replacement which was inserted on (b)(6)2020.The surgeon reported that the implant has failed to extend in recent attempts.The x-ray images provided show that the implant was extended by 36mm on (b)(6) 2021 image and has minimal changes on (b)(6) 2022 image, so that no distinction extension has been made during this period.Therefore, the radiographic review can confirm the clinical report.Device history review: review of the product history records indicate the device was manufactured with no reported relevant discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusion: on 17mar2022, the investigator confirmed that drive unit passed its annual maintenance, confirming that drive unit is working accordingly.A review of the associated ifu "drive unit to be used with jts extendible implants" states the following "[.] please contact your local representative or stanmore implants for training".Moreover "booster switch to only be used by qualified service personnel".The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, pathology reports, progress notes, additional x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
 
Event Description
It has been reported there are issues lengthening the patient's distal femur jts.As reported: we repeated lengthening procedures 11 times (booster 3, driver a, 30 minutes time).We obtained initial lengthening of 36mm, but since 1 year, the lengthening is stopped despite the lengthening procedures.However, the theoretical lengthening was until 65mm.
 
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Brand Name
DISTAL FEMUR JTS - EXTENSION MECHANISM
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
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 Key13497571
MDR Text Key289221721
Report Number3004105610-2022-00015
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K133152
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2020
Device Catalogue NumberUNK_STM
Device Lot NumberPIN 22249
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/20/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age13 YR
Patient SexFemale
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