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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ROTATIONAL KNEE JOINT PROSTHESIS ENDO-MODEL® ROTATING HINGED TOTAL KNEE PROSTHESIS

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WALDEMAR LINK GMBH & CO. KG ROTATIONAL KNEE JOINT PROSTHESIS ENDO-MODEL® ROTATING HINGED TOTAL KNEE PROSTHESIS Back to Search Results
Model Number 15-8024/11
Device Problem Naturally Worn (2988)
Patient Problem Failure of Implant (1924)
Event Date 09/16/2015
Event Type  Injury  
Manufacturer Narrative
All product features corresponded with the valid specifications of the waldemar link (b)(4) at the time, when the item was produced. Functional overload probably led to bushing damage, which may have been favoured by the varicose position of the tibial component. The final cause of the bushing damage could not be determined. Ultimately, the final decision for an implant must be made by the surgeon based on his individual analysis and experience for each patient. The studies by e. Nieder and e. Nieder, among others, provide assistance in this respect. Katzer provide information. These studies are indicated both in the surgical technique and in the catalogue. In this case, we recommend the use of a hinged knee, as due to bone defects an insufficient extensor inhibition by the soft tissue apparatus and here a hinge knee is a more stable solution in terms of which offers lower belt tension. The examination of the complaint sample did not reveal any evidence of a material or manufacturing defects causing the damage. The report is delayed due to inconsistencies with regard to foreign event reporting to fda. After re-evaluation of the complaint we determined that it is reportable. We have addressed the inconsistency in reporting foreign events to fda through capa-(b)(4).
 
Event Description
Defect bushing after 4 years and 8 months.
 
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Brand NameROTATIONAL KNEE JOINT PROSTHESIS ENDO-MODEL®
Type of DeviceROTATING HINGED TOTAL KNEE PROSTHESIS
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM 22339
Manufacturer (Section G)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM 22339
Manufacturer Contact
omid rahmatian
barkhausenweg 10
hamburg, 22339
GM   22339
MDR Report Key8296674
MDR Text Key134724498
Report Number3004371426-2019-00022
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K143179
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial
Report Date 09/17/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number15-8024/11
Device Catalogue Number15-8024/11
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2015
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/01/2019 Patient Sequence Number: 1
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