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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL® MODULAR KNEE SYSTEM
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WALDEMAR LINK GMBH & CO. KG ENDO-MODEL® MODULAR KNEE SYSTEM Back to Search Results
Model Number 15-2818/11
Device Problems Break (1069); Fracture (1260)
Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)
Event Date 12/17/2018
Event Type  Injury  
Event Description
Change roknep m after shaft break.Femur was loosened in the cement coat and could be pulled out easily.Tibial shaft was firm and had to be knocked out.The patient was again provided with a new roknep m.
 
Manufacturer Narrative
[translate].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 period, when the item was produced.On the basis of the provided pictures of the complaint sample, a fracture of the female cone of the modular shaft can be confirmed.The complaint samples were not available for examination.The first signs of loosening and first axial deviations can already be seen in the x-ray images taken in 2013.The x-rays from 2018 show a fracture in the proximal tibial prosthesis at the tapered connection to the shaft.Furthermore, an osteolysis at the transition to the femoral component is visible at the distal femur.The bmi of the patient is 45.7.According to our instructions for use, obesity is a relative contraindication.Taking these circumstances into consideration, as well as a prosthesis service life of more than 7 years, a material or manufacturing defect causing the damage is excluded.Rather, the cause of the primary loosening and secondary fracture is due to patient-related overloading of the implant components.Whether the described car accident contributed to the fracture is not comprehensible.
 
Event Description
Change roknep m after shaft break.Femur was loosened in the cement coat and could be pulled out easily.Tibial shaft was firm and had to be knocked out.The patient was again provided with a new roknep m.
 
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Brand Name
ENDO-MODEL® MODULAR KNEE SYSTEM
Type of Device
ENDO-MODEL® MODULAR KNEE SYSTEM
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM  22339
MDR Report Key8252786
MDR Text Key133219621
Report Number3004371426-2019-00003
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
K143179
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/17/2018
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 Health Professional
Device Expiration Date06/30/2016
Device Model Number15-2818/11
Device Catalogue Number15-2818/11
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/17/2018
Initial Date FDA Received01/16/2019
Supplement Dates Manufacturer Received12/17/2018
Supplement Dates FDA Received06/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age77 YR
Patient Weight117
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