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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MODULAR JOINT COMPONENT UNIT - CEMENTABLE INTRACONDYLAR - MEGASYSTEM-C ROTATING HINGED TOTAL KNEE PROSTHESIS

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WALDEMAR LINK GMBH & CO. KG MODULAR JOINT COMPONENT UNIT - CEMENTABLE INTRACONDYLAR - MEGASYSTEM-C ROTATING HINGED TOTAL KNEE PROSTHESIS Back to Search Results
Model Number 15-8521/25
Device Problems Crack (1135); Naturally Worn (2988)
Patient Problem Failure of Implant (1924)
Event Date 12/21/2015
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 gmbh & co. Kg at the time, when the item was produced. The reported event is confirmed through investigation. The investigation of the complaint sample showed no deviations and gave no indication which led to a material or manufacturing fault. According to the quality documentation review and the investigation results we exclude a product failure. 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
It was reported that a revision surgery was performed due to luxation of the right knee.
 
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Brand NameMODULAR JOINT COMPONENT UNIT - CEMENTABLE INTRACONDYLAR - MEGASYSTEM-C
Type of DeviceROTATING HINGED TOTAL KNEE PROSTHESIS
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM 22339
Manufacturer Contact
rebekka winterhoff
barkhausenweg 10
hamburg, 22339
GM   22339
MDR Report Key8296339
MDR Text Key134706636
Report Number3004371426-2019-00031
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeCO
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 01/06/2016
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 Expiration Date04/30/2015
Device Model Number15-8521/25
Device Catalogue Number15-8521/25
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2016
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2010
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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