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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 PROSTHESIS SYSTEM
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WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL KNEE PROSTHESIS SYSTEM Back to Search Results
Model Number 15-8523/44
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Joint Laxity (4526)
Date of Event 07/11/2023
Type of Reportable Event Serious Injury
Event or Problem Description
As reported by representative t.A., on 2023-07-12, after a surgery performed on (b)(6) 2023 with dr.(b)(6), the stem disassociated from the femur, after being cemented when patient was moved from or to recovery, approximately 45 minutes after surgery.
 
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Brand Name
ENDO-MODEL SL KNEE PROSTHESIS SYSTEM
Common Device Name
ENDO-MODEL SL KNEE PROSTHESIS SYSTEM
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM  22339
MDR Report Key17390839
Report Number3006721341-2023-00017
Device Sequence Number6808788
Product Code KRO
UDI-Device Identifier04026575384242
UDI-Public(01)04026575384242(17)271031(10)22224077
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2023
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/25/2023
Report Date (Section F) 07/12/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device 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? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/12/2023
Event Location Hospital
Date Report to Manufacturer07/12/2023
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/25/2023
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age86 YR
Patient SexMale
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