MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA CEMENTED STEMMED TIBIAL TRAY LEFT SIZE F; PROSTHESIS, KNEE

Model Number N/A

Device Problems Use of Device Problem (1670); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 11/21/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : investigation incomplete.

Event Description

It was reported that while the surgeon was performing a left knee arthroplasty, the left knee tibial tray was opened.The outer and inner label were confirmed to be identical and there were no difficulties implanting the tibial tray.However, upon having difficulty seating the left articular surface, it was identified that the etch on the tibial tray was for a right knee, rather than a left knee.As there were no issues with the fit of the tibial tray and the cement had already cured, the surgeon opted to leave the right tibial tray in the knee and a right articular surface was used to complete the procedure.The patient has since experienced no post-operative complications and the surgeon does not plan to revise the patient.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The reported event was confirmed by review of provided pictures, which identified that a right tibial tray was implanted into the patient's left knee.The provided picture also shows that the box in which the device was packaged, is labeled for a left knee.As the device was not able to be returned, further evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Products were reviewed for compatibility and it was noted that the left femur which was implanted, is not compatible with the right tibial tray and articular surface.Radiographs were provided, however they were not reviewed by a third party as it was determined it would not enhance the investigation.The root cause of the reported issue is attributed to manufacturing error.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional information to report.

• Brand Name: PERSONA CEMENTED STEMMED TIBIAL TRAY LEFT SIZE F
• 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: 18344396
• MDR Text Key: 330804739
• Report Number: 3007963827-2023-00340
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024471078
• UDI-Public: (01)00889024471078(17)311122(10)65284815
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122765
• 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,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• 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: 42532007501
• Device Lot Number: 65284815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2021
• 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 Sex: Prefer Not To Disclose