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U.S. Department of Health and Human Services

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

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WALDEMAR LINK GMBH & CO. KG ENDO-MODEL ROTATIONAL KNEE PROSTHESIS REPLACEMENT SET ROTATING HINGED TOTAL KNEE PROSTHESIS Back to Search Results
Catalog Number 15-0027/12
Device Problems Material Integrity Problem (2978); Naturally Worn (2988)
Patient Problem Failure of Implant (1924)
Event Date 06/22/2021
Event Type  Injury  
Event Description
It was reported that a revision surgery was performed due to instability and wear.
 
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Brand NameENDO-MODEL ROTATIONAL KNEE PROSTHESIS REPLACEMENT SET
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 Key12850471
MDR Text Key282549130
Report Number3004371426-2021-00031
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K143179
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number15-0027/12
Device Lot Number1731115X
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received11/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/22/2021 Patient Sequence Number: 1
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