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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG FEMORAL TRIAL PROSTHESIS WITH FLANGE
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WALDEMAR LINK GMBH & CO. KG FEMORAL TRIAL PROSTHESIS WITH FLANGE Back to Search Results
Model Number 15-3234/26
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Bone Fracture(s) (1870)
Event Date 03/04/2019
Event Type  Injury  
Manufacturer Narrative
The review of the device history record showed no deviations.All product features corresponded with the valid specifications of the waldemar link (b)(4) at the time, when the item was produced.
 
Event Description
After box cuts were made, surgeon placed the metal femoral trial with an 18mm trial stem and the trial assembly would not seat.Upon removal of the trial stem, the femoral trial was again placed but did not seat.It was noted by the assisting physician that the box cuts were narrower at the end of the cuts, likely due to blade deflection.The box cuts were then opened more, and the femoral trial was able to be seated to within approximately 3-55mm of a desired flush position.The surgeon then impacted the trail, cracking the medial condyle at the superior medial box cut corner.A cannulated screw was placed to fix the condyle to the femur.The surgery proceeded without further complications and the total joint implants were implanted successfully.
 
Manufacturer Narrative
The review of the device history record showed no deviations.All product features corresponded with the valid specifications of the waldemar link gmbh & co.Kg at the time, when the item was produced.
 
Event Description
After box cuts were made, surgeon placed the metal femoral trial with an 18mm trial stem and the trial assembly would not seat.Upon removal of the trial stem, the femoral trial was again placed but did not seat.It was noted by the assisting physician that the box cuts were narrower at the end of the cuts, likely due to blade deflection.The box cuts were then opened more, and the femoral trial was able to be seated to within approximately 3-55mm of a desired flush position.The surgeon then impacted the trail, cracking the medial condyle at the superior medial box cut corner.A cannulated screw was placed to fix the condyle to the femur.The surgery proceeded without further complications and the total joint implants were implanted successfully.
 
Manufacturer Narrative
The review of the device history record showed no deviations.All product features corresponded with the valid specifications of the waldemar link gmbh & co.Kg at the time, when the item was produced.The visual inspection of the femoral trial prosthesis shows no deviation.Merely traces of normal wear can be seen at the surface which indicates a frequent use of the product.A functional and dimensional test confirmed that all features correspond to the valid specification.No similar complaints were received regarding this article.Regarding the surgical technique additional resection is required if the cutting box or femoral trial could not be inserted properly due to bony resistance.This resistance could be the result of blade deflection but should not be overcome with impacts rather with additional resection.A material or device failure is not assumed.Rather it is assumed that the fracture of the medial condyles occurred due to improper preparation of the bone.
 
Event Description
After box cuts were made, surgeon placed the metal femoral trial with an 18mm trial stem and the trial assembly would not seat.Upon removal of the trial stem, the femoral trial was again placed but did not seat.It was noted by the assisting physician that the box cuts were narrower at the end of the cuts, likely due to blade deflection.The box cuts were then opened more, and the femoral trial was able to be seated to within approximately 3-55mm of a desired flush position.The surgeon then impacted the trail, cracking the medial condyle at the superior medial box cut corner.A cannulated screw was placed to fix the condyle to the femur.The surgery proceeded without further complications and the total joint implants were implanted successfully.
 
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Brand Name
FEMORAL TRIAL PROSTHESIS WITH FLANGE
Type of Device
FEMORAL TRIAL PROSTHESIS WITH FLANGE
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM  22339
MDR Report Key8478018
MDR Text Key140772282
Report Number3004371426-2019-00119
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
LIST A276176
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup,Followup
Report Date 03/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number15-3234/26
Device Catalogue Number15-3234/26
Device Lot NumberB434017
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2019
Date Manufacturer Received03/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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