MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO.KG ENDO-MODEL SL KNEE JOINT PROSTHESIS; MODULAR STEM, UNCEMENTED, MALE TAPER, TI6AL4V, CONICAL, L=160 MM, Ø19 / 14 MM

Model Number	15-8522/57
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	01/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Information received from surgeon (b)(6) 2024 suggests that the design of this cone and stem construct may not have been well suited for this patient: the surgeon noted on (b)(6) 2024 that the wl cones address metaphyseal area but do not address meta-diaphyseal ingrowth, especially when used with cementless stems (as in this case).The subject components were implanted by dr.(b)(6) during revision knee surgery on (b)(6) 2022.Patient complained of pain located in medial and lateral right knee starting after surgery.Due to pain and femoral stem loosening, the patient's knee was revised on (b)(6) 2024.Femoral side implants were replaced with custom-made femoral stem (lbio ref: cus-736, wl ref: (b)(4)), and standard items 15-8521/10 (total condylar replacement) and 15-0027/15 (replacement plateau).[customer].
Additional Manufacturer Narrative
This is the final supplemental report, the complaint is closed.
Event or Problem Description
Information received from surgeon (b)(6) 2024 suggests that the design of this cone and stem construct may not have been well suited for this patient: the surgeon noted on (b)(6) 2024 that the wl cones address metaphyseal area but do not address meta-diaphyseal ingrowth, especially when used with cementless stems (as in this case).The subject components were implanted by dr.M.During revision knee surgery on (b)(6) 2022.Patient complained of pain located in medial and lateral right knee starting after surgery.Due to pain and femoral stem loosening, the patient's knee was revised on (b)(6) 2024.Femoral side implants were replaced with custom-made femoral stem (lbio ref: (b)(6), wl ref: case 2023_0468), and standard items (b)(6) (total condylar replacement) and (b)(6) (replacement plateau).[customer].
Additional Manufacturer Narrative
This is the final supplemental report, the complaint is closed.
Event or Problem Description
Information received from surgeon 18-jan-2024 suggests that the design of this cone and stem construct may not have been well suited for this patient: the surgeon noted on (b)(6) 2024 that the wl cones address metaphyseal area but do not address meta-diaphyseal ingrowth, especially when used with cementless stems (as in this case).The subject components were implanted by dr.(b)(6) during revision knee surgery on (b)(6) 2022.Patient complained of pain located in medial and lateral right knee starting after surgery.Due to pain and femoral stem loosening, the patient's knee was revised on (b)(6) 2024.Femoral side implants were replaced with custom-made femoral stem (lbio ref: (b)(4), wl ref: case (b)(4)), and standard items 15-8521/10 (total condylar replacement) and 15-0027/15 (replacement plateau).[customer].

• Brand Name: ENDO-MODEL SL KNEE JOINT PROSTHESIS
• Common Device Name: MODULAR STEM, UNCEMENTED, MALE TAPER, TI6AL4V, CONICAL, L=160 MM, Ø19 / 14 MM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO.KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: annerike tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 18719245
• Report Number: 3004371426-2024-00011
• Device Sequence Number: 9384031
• Product Code: KRO
• UDI-Device Identifier: 04026575383849
• UDI-Public: 04026575383849
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K151008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: 15-8522/57
• Device Catalogue Number: 15-8522/57
• Device Lot Number: 2130188
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2024
• Supplement Date Received by Manufacturer: 01/19/2024; 01/19/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 04/09/2024; 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male