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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL REPLACEMENT PLATEAU ROTATING HINGED TOTAL KNEE PROSTHESIS

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WALDEMAR LINK GMBH & CO. KG ENDO-MODEL REPLACEMENT PLATEAU ROTATING HINGED TOTAL KNEE PROSTHESIS Back to Search Results
Catalog Number 15-0027/14
Device Problem Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/21/2022
Event Type  malfunction  
Event Description
It was reported that the two polyethylene plateaus did not fit, and the surgeon had to clean and reuse the original part. Surgeon reports that the replacement part fit in front but not in the grooves in the back. The parts were discarded after the procedure.
 
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Brand NameENDO-MODEL REPLACEMENT PLATEAU
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 Key13926455
MDR Text Key288878024
Report Number3004371426-2022-00005
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K143179
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number15-0027/14
Device Lot Number2148157
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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