MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINKSYMPHOKNEE; ARTICULATING SURFACE - X-LINKED VIT-E PE - SZ. 1-2 CR 10MM 20MM

Model Number	880-241/10
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Dr.(b)(6) reported that an lsk cr poly was removed in a revision surgery on (b)(6) 2024, because of a disassociation/loosening.[customer].
Event or Problem Description
Dr.(b)(6) reported that an lsk cr poly was removed in a revision surgery on (b)(6) 2024, because of a disassociation/loosening.[customer].
Additional Manufacturer Narrative
This is the final supplemental report.The complaint is closed.

• Brand Name: LINKSYMPHOKNEE
• Common Device Name: ARTICULATING SURFACE - X-LINKED VIT-E PE - SZ. 1-2 CR 10MM 20MM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: andreas brandt ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 19432708
• Report Number: 3004371426-2024-00040
• Device Sequence Number: 8299104
• Product Code: HRY
• UDI-Device Identifier: 04026575246281
• UDI-Public: 04026575246281
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K202924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2023

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
• Device Model Number: 880-241/10
• Device Catalogue Number: 880-241/10
• Device Lot Number: 2202045
• 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: 05/02/2024
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 05/31/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2022
• 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 Sex: Unknown