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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO.KG LINKSYMPHOKNEE; ARTICULATING SURFACE, SYMMETRIC, SZ. 5-6, UHMWPE PS, FIXED, H= 10 MM
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WALDEMAR LINK GMBH & CO.KG LINKSYMPHOKNEE; ARTICULATING SURFACE, SYMMETRIC, SZ. 5-6, UHMWPE PS, FIXED, H= 10 MM Back to Search Results
Model Number 880-215/10
Device Problem Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2024
Event Type  malfunction  
Event Description
The insert does not fully adhere to the tibia at the front and therefore does not lock.The item was discarded because of this malfunction and we used another new insert (ps+), which fitted at the first attempt without any problem.[customer].
 
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Brand Name
LINKSYMPHOKNEE
Type of Device
ARTICULATING SURFACE, SYMMETRIC, SZ. 5-6, UHMWPE PS, FIXED, H= 10 MM
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO.KG
barkhausenweg 10
hamburg, hamburg 22339
GM  22339
Manufacturer Contact
tizia hucklenbroch
barkhausenweg 10
hamburg, hamburg 22339
GM   22339
MDR Report Key19057527
MDR Text Key340466942
Report Number3004371426-2024-00029
Device Sequence Number1
Product Code HRY
UDI-Device Identifier04026575253159
UDI-Public04026575253159
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K202924
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 03/13/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number880-215/10
Device Catalogue Number880-215/10
Device Lot Number2334113
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/21/2024
Initial Date Manufacturer Received 03/13/2024
Initial Date FDA Received04/08/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/01/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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