MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO.KG LINKSYMPHOKNEE; ARTICULATING SURFACE, SYMMETRIC, SZ. 5-6 X-LINKED VIT-E PE, PS, FIXED, H= 12 MM

Model Number	880-255/12
Medical Device Problem Codes	Positioning Failure (1158); Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Poly insert would not engage into the tibial tray during a surgery.[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.
Event or Problem Description
Poly insert would not engage into the tibial tray during a surgery.[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
Device used for oncological resection of the right distal femur.Atraumatic component fracture.[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.For cause investigation - investigation conclusion the imdrf-code d20 was used: cause traced to another device.

• Brand Name: LINKSYMPHOKNEE
• Common Device Name: ARTICULATING SURFACE, SYMMETRIC, SZ. 5-6 X-LINKED VIT-E PE, PS, FIXED, H= 12 MM
• 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: 17147438
• Report Number: 3004371426-2023-00046
• Device Sequence Number: 5818530
• Product Code: HRY
• UDI-Device Identifier: 04026575255962
• UDI-Public: 04026575255962
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 880-255/12
• Device Catalogue Number: 880-255/12
• Device Lot Number: 221260
• 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: 05/18/2023
• Supplement Date Received by Manufacturer: 11/07/2022; 05/18/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 08/15/2023; 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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: 65 YR
• Patient Sex: Male