MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM; FEMORAL SPACER, S4,80 MM, SMALL, LEFT,ENDO-M. MODUL. KNEEP. SYSTEM

Model Number	15-2964/02
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Bone Shedding Debris (4557)
Date of Event	06/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.
Event or Problem Description
The patient's follow-up visit notes were sent to linkbio on 2023-06-28.The most recent follow-up visit note dated (b)(6) 2023 indicates that the patient has distal femur pain with radiographic studies showing loosening of the femoral cement mantle and stem, which dr.(b)(6) thinks may be resulting from the polyethylene augment that she has on the femoral side.Dr.(b)(6) plans to revise the femoral side with a custom design.[customer].
Additional Manufacturer Narrative
The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.
Event or Problem Description
The most recent follow-up visit note dated (b)(6) 2023 indicates that the patient has distal femur pain with radiographic studies showing loosening of the femoral cement mantle and stem.[customer].

• Brand Name: ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM
• Common Device Name: FEMORAL SPACER, S4,80 MM, SMALL, LEFT,ENDO-M. MODUL. KNEEP. SYSTEM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 17403279
• Report Number: 3004371426-2023-00055
• Device Sequence Number: 20324098
• Product Code: KRO
• UDI-Device Identifier: 04026575205875
• UDI-Public: 04026575205875
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K211768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2023
• 2 Devices were Involved in the Event: 1 2

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: 07/31/2026
• Device Model Number: 15-2964/02
• Device Catalogue Number: 15-2964/02
• Device Lot Number: 2131015
• 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: 06/29/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2021
• 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: 64 YR
• Patient Sex: Female
• Patient Weight: 69 KG