MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINKSYMPHOKNEE; POLYETHYLENPLATEAU, SYMMETRISCH GR. 3-4, X-LINKED VIT-E PE

Model Number	880-243/10
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.(b)(6) performed a revision for a poly swap for a patient who presented with discomfort.The implant was originally done in a bilateral procedure on (b)(6) 20221.The revision was completed on (b)(6) 2024 to the right side.Only the poly was revised.Dr.(b)(6) thinks the polys are too thin, that tolerances aren't sufficient.The original was a size 10 cr but the swap was with a size 12 uc poly.The patient also has a size 10 poly on the left side and has reported similar discomfort.The part will not be returned for the investigation.[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
Dr.(b)(6) performed a revision for a poly swap for a patient who presented with discomfort.The implant was originally done in a bilateral procedure on (b)(6) 2022.The revision was completed on (b)(6) 2024 to the right side.Only the poly was revised.Dr.(b)(6) thinks the polys are too thin, that tolerances aren't sufficient.The original was a size 10 cr but the swap was with a size 12 uc poly.The patient also has a size 10 poly on the left side and has reported similar discomfort.The part will not be returned for the investigation.[customer].

• Brand Name: LINKSYMPHOKNEE
• Common Device Name: POLYETHYLENPLATEAU, SYMMETRISCH GR. 3-4, X-LINKED VIT-E PE
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 20852058
• Report Number: 3004371426-2024-00076
• Device Sequence Number: 15439343
• Product Code: HRY
• UDI-Device Identifier: 04026575255344
• UDI-Public: 04026575255344
• 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: 2022
• 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): 11/13/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 880-243/10
• Device Catalogue Number: 880-243/10
• Device Lot Number: 2213186
• 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: 12/13/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2022
• 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