MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA POSTERIOR STABILIZED ARTICULAR SURFACE LEFT 10MM; PROSTHESIS, KNEE

Model Number N/A

Device Problems Difficult to Insert (1316); Material Deformation (2976)

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

Event Date 09/27/2023

Event Type  malfunction  

Event Description

It was reported that during knee arthroplasty, the articular surface could not be seated on the tibial tray.Upon inspection of the articular surface implant, it appeared to have a burr molded into the seating surface.Another articular surface was used to complete the procedure.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

(b)(4).D10 - concomitant devices - persona cemented stemmed tibial component left size f catalog #: 42532007501 lot #: 66188671 g2 - report source - foreign: event occurred in spain the complainant has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : investigation incomplete.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The reported event was confirmed with the returned device.Visual examination of the product identified distal surface damage (nicked/gouged) and the dovetail feature compressed and flared.Review of the device history records identified no deviations or anomalies during manufacturing.Damage to the articular surface can occur if the articular surface is not correctly placed and oriented before pushing it with the inserter instrument.Instructions for use are provided in the surgical technique; thus, root cause is attributed to use 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.

• Brand Name: PERSONA POSTERIOR STABILIZED ARTICULAR SURFACE LEFT 10MM
• 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: 17905052
• MDR Text Key: 325291279
• Report Number: 3007963827-2023-00270
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024641341
• UDI-Public: (01)00889024641341(17)280806(10)66219273
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K113369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

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: 42511400710
• Device Lot Number: 66219273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 02/05/2024
• Supplement Dates FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2023
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Sex: Prefer Not To Disclose