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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 JOINT PROSTHESIS; MODULAR STEMS WITH MALE TAPER (FOR 6 MM FLANGES)
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WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL KNEE JOINT PROSTHESIS; MODULAR STEMS WITH MALE TAPER (FOR 6 MM FLANGES) Back to Search Results
Model Number 15-8523/44
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Failure of Implant (1924)
Event Date 07/11/2023
Event Type  malfunction  
Event Description
As reported by representative, on 2023-07-12, after a surgery performed on (b)(6) 2023,the stem disassociated from the femur, after being cemented when patient was moved from or to recovery, approximately 45 minutes after surgery.The product seemed well fixed with cement prior to closing.[customer].
 
Manufacturer Narrative
The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.This is the final supplemental report, the complaint is closed.
 
Event Description
As reported by representative, on 2023-07-12, after a surgery performed on (b)(6) 2023,the stem disassociated from the femur, after being cemented when patient was moved from or to recovery, approximately 45 minutes after surgery.The product seemed well fixed with cement prior to closing.[customer].
 
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Brand Name
ENDO-MODEL SL KNEE JOINT PROSTHESIS
Type of Device
MODULAR STEMS WITH MALE TAPER (FOR 6 MM FLANGES)
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM  22339
Manufacturer Contact
lisa effe
barkhausenweg 10
hamburg, 22339
GM   22339
MDR Report Key17496505
MDR Text Key320754800
Report Number3004371426-2023-00068
Device Sequence Number1
Product Code KRO
UDI-Device Identifier04026575384242
UDI-Public04026575384242
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/12/2023
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 Operator Health Professional
Device Model Number15-8523/44
Device Catalogue Number15-8523/44
Device Lot Number2224077
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/12/2023
Initial Date FDA Received08/10/2023
Supplement Dates Manufacturer Received07/12/2023
Supplement Dates FDA Received11/06/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age86 YR
Patient SexMale
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