MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA 0° SPIKED KEEL LEFT SIZE F OSSEOTI TIBIA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Malposition of Device (2616)

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

Event Date 02/19/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that while inserting the implant using the appropriate instrument, the tibial component shifted and slide posteriorly by about 4mm from the trial.The surgeon left the tibial component implanted.The patient has not experienced any complications since implantation.Attempts have been made and all available information has been provided.

• Brand Name: PERSONA 0° SPIKED KEEL LEFT SIZE F OSSEOTI TIBIA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18895962
• MDR Text Key: 337573558
• Report Number: 3007963827-2024-00066
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024631946
• UDI-Public: (01)00889024631946(17)330803(10)65968931
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2024

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 Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42535007501
• Device Lot Number: 65968931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Female