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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 ROTATIONAL HINGED TOTAL KNEE PROSTHESIS

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WALDEMAR LINK GMBH & CO. KG ENDO-MODEL® ROTATIONAL KNEE PROSTHESIS ROTATIONAL HINGED TOTAL KNEE PROSTHESIS Back to Search Results
Model Number 15-2818/12
Device Problem Naturally Worn (2988)
Patient Problem Failure of Implant (1924)
Event Date 05/03/2017
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. A functional test of the rotational bushing assembled to a tibial test component indicated no deviation. According to investigation results and production documents a product failure is not assumed. 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 and plateau. Instability of prosthesis.
 
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Brand NameENDO-MODEL® ROTATIONAL KNEE PROSTHESIS
Type of DeviceROTATIONAL 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
annerike kleine
barkhausenweg 10
hamburg, 
GM  
MDR Report Key8296633
MDR Text Key134725310
Report Number3004371426-2019-00063
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 05/08/2017
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 Number15-2818/12
Device Catalogue Number15-2818/12
Device Lot Number1523202 (BUSHING)
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2017
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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