MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL ROTATIONAL AND HINGE KNEE PROTHESIS SYSTEM; REPLACEMENT SETS, SPAREPART KIT BEARING BOXES FOR ENDO-MODEL SL, UHMWPE

Model Number	16-2011/21
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Axis did not fit into bearing.
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
Axis did not fit into bearing [customer].

• Brand Name: ENDO-MODEL SL ROTATIONAL AND HINGE KNEE PROTHESIS SYSTEM
• Common Device Name: REPLACEMENT SETS, SPAREPART KIT BEARING BOXES FOR ENDO-MODEL SL, UHMWPE
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 16588891
• Report Number: 3004371426-2023-00013
• Device Sequence Number: 5896031
• Product Code: KRO
• UDI-Device Identifier: 04026575222049
• UDI-Public: 04026575222049
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 16-2011/21
• Device Catalogue Number: 16-2011/21
• Device Lot Number: 2206438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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: 80 YR
• Patient Sex: Female