MAUDE Adverse Event Report: WALDEMAR LINK GMBH&CO.KG LINKSYMPHOKNEE; ARTICULATING SURFACE, SYMMETRIC, SZ. 7-8 X-LINKED VIT-E PE, PS, FIXED, H= 10 MM

Model Number 880-257/10

Device Problem Positioning Failure (1158)

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

Event Date 06/27/2023

Event Type  malfunction  

Event Description

Poly insert would not engage into the tibial tray.[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.

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 Description

Poly insert would not engage into the tibial tray.[customer].

• Brand Name: LINKSYMPHOKNEE
• Type of Device: ARTICULATING SURFACE, SYMMETRIC, SZ. 7-8 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: 17403280
• MDR Text Key: 320131301
• Report Number: 3004371426-2023-00056
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 04026575256006
• UDI-Public: 04026575256006
• 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,Followup
• Report Date: 07/07/2023

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
• Device Model Number: 880-257/10
• Device Catalogue Number: 880-257/10
• Device Lot Number: 2133008
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/07/2023
• Initial Date FDA Received: 07/27/2023
• Supplement Dates Manufacturer Received: 07/07/2023
• Supplement Dates FDA Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• 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: 70 YR
• Patient Sex: Male