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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL KNEE PROSTHESIS SYSTEM
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WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL KNEE PROSTHESIS SYSTEM Back to Search Results
Model Number 16-2840/05
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Joint Laxity (4526)
Event Date 03/01/2024
Event Type  Injury  
Event Description
Notified on 3/6/2024 by representative m.Plate, that on (b)(6) 2024, dr.M.Performed a revision surgery for an endo sl that had a disassociated connection component.At review of pre-op x-rays it was still unclear as to the issue.When opened, it was clear that the components were disassociated.All the disassociated pieces were removed and this extended the surgery approximately 30 minutes.
 
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Brand Name
ENDO-MODEL SL KNEE PROSTHESIS SYSTEM
Type of Device
ENDO-MODEL SL KNEE PROSTHESIS SYSTEM
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM  22339
MDR Report Key18880866
MDR Text Key337406272
Report Number3006721341-2024-00005
Device Sequence Number1
Product Code KRO
UDI-Device Identifier04026575359240
UDI-Public04026575359240
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/06/2024,03/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2021
Device Model Number16-2840/05
Device Catalogue Number16-2840/05
Device Lot Number160602
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/01/2024
Device Age8 YR
Event Location Hospital
Date Report to Manufacturer03/06/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age75 YR
Patient SexMale
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