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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL M ROTATIONAL KNEE JOINT PROSTHESIS,TIBIAL COMPONENT UNCOATED KNEE TIBIA/INSERT PROSTHESIS

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WALDEMAR LINK GMBH & CO. KG ENDO-MODEL M ROTATIONAL KNEE JOINT PROSTHESIS,TIBIAL COMPONENT UNCOATED KNEE TIBIA/INSERT PROSTHESIS Back to Search Results
Catalog Number 15-2814/03
Device Problems Break (1069); Loose or Intermittent Connection (1371)
Patient Problem Failure of Implant (1924)
Event Date 02/09/2022
Event Type  Injury  
Event Description
It was reported that the sales representative was called in to or because the surgeon (dr. (b)(6)) needed to swap out a poly piece from tibial component that was implanted on (b)(6) 2021. When sales rep arrived in the or, he learned from surgeon's nurse that poly was loose, and the screw was floating. Additionally, the nurse stated that there may have been cement on the tibia baseplate. Surgeon examined the tibia and realized that the tip of the poly locking screw had broken off in the screw hole of the tibia. Surgeon was able to remove the baseplate without taking the stem out and replaced the tibial component. Per sales rep and surgeons nurse, they both believe that the poly was not engaged properly, and the screw was forced in and potentially caused the loosening.
 
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Brand NameENDO-MODEL M ROTATIONAL KNEE JOINT PROSTHESIS,TIBIAL COMPONENT
Type of DeviceUNCOATED KNEE TIBIA/INSERT 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 Key13756207
MDR Text Key287107542
Report Number3004371426-2022-00002
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143179
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Type of Report Initial
Report Date 03/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number15-2814/03
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received03/03/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/01/2021
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: 03/14/2022 Patient Sequence Number: 1
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