MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO.KG LINKSYMPHOKNEE; LINKSYMPHOKNEE SYSTEM, ARTICULATING SURFACE, SYMMETRIC, SZ. 5-6 X-LINKED VIT-E P

Model Number 880-255/10

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2023

Event Type  malfunction  

Event Description

The tibial poly was opened but not used.The returned poly would not work with the tibial base plate.An additional poly was opened and used without issue.[customer].

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.

• Brand Name: LINKSYMPHOKNEE
• Type of Device: LINKSYMPHOKNEE SYSTEM, ARTICULATING SURFACE, SYMMETRIC, SZ. 5-6 X-LINKED VIT-E P
• 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: 18272613
• MDR Text Key: 329809630
• Report Number: 3004371426-2023-00107
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 880-255/10
• Device Catalogue Number: 880-255/10
• Device Lot Number: 2228222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male