MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL KNEE JOINT PROSTHESIS; MODULAR STEMS WITH MALE TAPER (FOR 6 MM FLANGES)

Model Number	15-8523/44
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by representative, on 2023-07-12, after a surgery performed on (b)(6) 2023,the stem disassociated from the femur, after being cemented when patient was moved from or to recovery, approximately 45 minutes after surgery.The product seemed well fixed with cement prior to closing.[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
As reported by representative, on 2023-07-12, after a surgery performed on (b)(6) 2023,the stem disassociated from the femur, after being cemented when patient was moved from or to recovery, approximately 45 minutes after surgery.The product seemed well fixed with cement prior to closing.[customer].

• Brand Name: ENDO-MODEL SL KNEE JOINT PROSTHESIS
• Common Device Name: MODULAR STEMS WITH MALE TAPER (FOR 6 MM FLANGES)
• 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: 17496505
• Report Number: 3004371426-2023-00068
• Device Sequence Number: 6374636
• Product Code: KRO
• UDI-Device Identifier: 04026575384242
• UDI-Public: 04026575384242
• 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: 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): 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 15-8523/44
• Device Catalogue Number: 15-8523/44
• Device Lot Number: 2224077
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• 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
• Patient Age: 86 YR
• Patient Sex: Male