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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL® ROTATIONAL KNEE PROSTHESIS UNCOATED KNEE FEMUR PROSTHESIS

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WALDEMAR LINK GMBH & CO. KG ENDO-MODEL® ROTATIONAL KNEE PROSTHESIS UNCOATED KNEE FEMUR PROSTHESIS Back to Search Results
Model Number 15-3816/11
Device Problem Naturally Worn (2988)
Patient Problem Failure of Implant (1924)
Event Date 05/21/2018
Event Type  Injury  
Manufacturer Narrative
All product features corresponded with the valid specifications of the (b)(4) at the time, when the item was produced. A damage pattern as in the present case is known from cases of damage after functional overload of the components due to obese constitution of patient and insufficient soft tissue tension. 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
Translation: wear of rotational bushing.
 
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Brand NameENDO-MODEL® ROTATIONAL KNEE PROSTHESIS
Type of DeviceUNCOATED KNEE FEMUR 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
annerike kleine
barkhausenweg 10
hamburg, 
GM  
MDR Report Key8296624
MDR Text Key134722761
Report Number3004371426-2019-00108
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 06/26/2018
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
Device Operator
Device Expiration Date11/30/2019
Device Model Number15-3816/11
Device Catalogue Number15-3816/11
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2014
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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