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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO MODEL MODULAR FEMUR AND TIBIA, POREX

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WALDEMAR LINK GMBH & CO. KG ENDO MODEL MODULAR FEMUR AND TIBIA, POREX Back to Search Results
Model Number 15-3816/12
Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/03/2019
Event Type  Injury  
Event Description
On (b)(6) 2017, link femoral component (part of 15-3816/12 assembly), link femoral segment (15-2973/02) and link stem (15-3950/05) link components were implanted during revision of a competitive knee system. On (b)(6) 2019, the link femoral component (part of 15-3816/12 assembly), link femoral segment (15-2973/02) and link stem (15-3950/05) were explanted due to femoral component loosening. They were replaced with a distal femoral replacement with porex (cm000097), a replacement set/porex (15-3027/11), cementless stem (15-8522/60), and stem segment (15-8522/02). Note: upon review of order records on (b)(6) 2019 related to the replacement component cm000097 (implanted on (b)(6) 2019), reviewer found that link components had been explanted during the surgery, and initiated this complaint file.
 
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Brand NameENDO MODEL MODULAR FEMUR AND TIBIA, POREX
Type of DeviceENDO MODEL MODULAR FEMUR AND TIBIA, POREX
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM 22339
MDR Report Key8446172
MDR Text Key139672661
Report Number3006721341-2019-00009
Device Sequence Number0
Product Code KRO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial
Report Date 03/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date07/31/2021
Device Model Number15-3816/12
Device Catalogue Number15-3816/12
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/27/2019
Event Location No Information
Date Report to Manufacturer03/04/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/22/2019 Patient Sequence Number: 1
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