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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG FEMORAL COMPONENT CONDYLAR REPLACEMENT MEGASYSTEM-C; UNCOATED KNEE FEMUR PROSTHESIS
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WALDEMAR LINK GMBH & CO. KG FEMORAL COMPONENT CONDYLAR REPLACEMENT MEGASYSTEM-C; UNCOATED KNEE FEMUR PROSTHESIS Back to Search Results
Catalog Number 15-8521/06
Device Problems Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Patient Problems Ossification (1428); Failure of Implant (1924); Synovitis (2094)
Event Date 04/20/2021
Event Type  Injury  
Event Description
We were initially informed that during a washout for an infection on (b)(6) 2021, the surgeon made an observation that the condyle cap of the femoral component had come loose.Upon review of the surgery report it was revealed that a loosening of the femoral component had occurred.
 
Event Description
We were initially informed that during a washout for an infection on (b)(6) 2021, the surgeon made an observation that the condyle cap of the femoral component had come loose.Upon review of the surgery report it was revealed that a loosening of the femoral component had occurred.
 
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Brand Name
FEMORAL COMPONENT CONDYLAR REPLACEMENT MEGASYSTEM-C
Type of Device
UNCOATED KNEE FEMUR PROSTHESIS
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM  22339
MDR Report Key12201481
MDR Text Key262619870
Report Number3004371426-2021-00021
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
K143179
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 07/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/30/2023
Device Catalogue Number15-8521/06
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/02/2021
Initial Date FDA Received07/21/2021
Supplement Dates Manufacturer Received07/02/2021
Supplement Dates FDA Received10/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age78 YR
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