MAUDE Adverse Event Report: WALDEMAR LINK GMBH&CO.KG LINKSYMPHOKNEE; ARTICULATING SURFACE, SYMMETRIC, SZ. 3-4 X-LINKED VIT-E PE, PS, FIXED, H= 10 MM

Model Number	880-253/10
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
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.The report is delayed due to original classification of the case as non-reportable.Due to the recent fda inspection we re-evaluated the complaint in comparison to similar complaints with different outcomes and therefore determined that it is reportable.We have addressed this observation in capa-23-08.
Event or Problem Description
Positioning failure of articulating surface in the tibial component.A different articulating surface was used instead.[customer].
Event or Problem Description
Poly plateau did not engage.[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.The initial report was delayed due to original classification of the case as non-reportable.Due to the recent fda inspection we re-evaluated the complaint in comparison to similar complaints with different outcomes and therefore determined that it is reportable.We have addressed this observation in capa-23-08.

• Brand Name: LINKSYMPHOKNEE
• Common Device Name: ARTICULATING SURFACE, SYMMETRIC, SZ. 3-4 X-LINKED VIT-E PE, PS, FIXED, H= 10 MM
• Manufacturer (Section D): WALDEMAR LINK GMBH&CO.KG; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: annerike-tizia hucklenbroch ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 17042331
• Report Number: 3004371426-2023-00045
• Device Sequence Number: 15581279
• Product Code: HRY
• UDI-Device Identifier: 04026575255771
• UDI-Public: 04026575255771
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2023

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: 880-253/10
• Device Catalogue Number: 880-253/10
• Device Lot Number: 2236087
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/22/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2023
• 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: 67 YR
• Patient Sex: Female