MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL; ENDO-MODEL -M, MODULAR STEMS, CEMENTED, COCRMO, TINBN, CONICAL, L= 135 MM, Ø=16

Model Number	15-3950/05
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	06/23/2025
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 link endo-model-m knee system was implanted on (b)(6) 2022.The surgeon suspects loosening of the cemented femoral stem and plans revision with cementless stems.[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.Update 10/14/2025: due to new received information, the problem description and the affected medical device have been updated / corrected.Instead of the femoral stem the tibial stem has been revised.The review of the device history record of the tibial stem showed no deviations.The product complies with the specifications valid at the time of manufacture.
Event or Problem Description
The link endo-model-m knee system was implanted on (b)(6) 2022.The surgeon suspects loosening of the cemented femoral stem and plans revision with cementless stems.[customer] update / correction (b)(6) 2025: surgeon suspects loosening of the proximal end of the tibial construct which included poly augments.Revision occured.[customer].
Event or Problem Description
The link endo-model-m knee system was implanted on (b)(6) 2022.The surgeon suspects loosening of the cemented femoral stem and plans revision with cementless stems.[customer]: update / correction 2025-10-09: surgeon suspects loosening of the proximal end of the tibial construct which included poly augments.Revision occured.[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.Update 10/14/2025: due to new received information, the problem description and the affected medical device have been updated / corrected.Instead of the femoral stem the tibial stem has been revised.The review of the device history record of the tibial stem 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.

• Brand Name: ENDO-MODEL
• Common Device Name: ENDO-MODEL -M, MODULAR STEMS, CEMENTED, COCRMO, TINBN, CONICAL, L= 135 MM, Ø=16
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: andreas brandt ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 22584667
• Report Number: 3004371426-2025-00036
• Device Sequence Number: 19958776
• Product Code: KRO
• UDI-Device Identifier: 04026575431670
• UDI-Public: 04026575431670
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K152431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• 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): 06/27/2025

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: 01/31/2025
• Device Model Number: 15-3950/05
• Device Catalogue Number: 15-3950/05
• Device Lot Number: 1941188
• 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: 06/27/2025
• Supplement Date Received by Manufacturer: 06/27/2025; 06/27/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 10/15/2025; 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2020
• 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: 78 YR
• Patient Sex: Male