MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL; PROXIMAL TIBIAL SPACER, CEMENTED, UHMWPE, 3 EA., S, H= 30 MM

Model Number	15-2516/29
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994)
Date of Event	08/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent knee revision surgery (b)(6) 2021 for a previously infected knee (manufacturer unknown) and nickel allergy.This tibial augment was implanted at that time with a link porex knee system.It appears that the femoral side was later revised (cause unknown) on (b)(6) 2023.Dr.Now plans to revise this patient due to right knee pain, which he suspects is related to the uhmwpe tibial augment.[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.This is the final supplemental report.The complaint is closed.
Event or Problem Description
The patient underwent knee revision surgery (b)(6) 2021 for a previously infected knee (manufacturer unknown) and nickel allergy.This tibial augment was implanted at that time with a link porex knee system.It appears that the femoral side was later revised (cause unknown) on (b)(6) 2023.Dr.Now plans to revise this patient due to right knee pain, which he suspects is related to the uhmwpe tibial augment.[customer].

• Brand Name: ENDO-MODEL
• Common Device Name: PROXIMAL TIBIAL SPACER, CEMENTED, UHMWPE, 3 EA., S, H= 30 MM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: andreas brandt ; barkhausenweg 10; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 20187871
• Report Number: 3004371426-2024-00062
• Device Sequence Number: 7003173
• Product Code: KRO
• UDI-Device Identifier: 04026575204212
• UDI-Public: 04026575204212
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K143179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2024

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: 07/30/2025
• Device Model Number: 15-2516/29
• Device Catalogue Number: 15-2516/29
• Device Lot Number: 2028156
• 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: 08/15/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2020
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 121 KG