MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL KNEE ARTICULAR SURFACE RIGHT MEDIAL SIZE E 8MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problem Pain (1994)

Event Date 04/30/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant devices - persona partial knee cemented femur size 4 right medial catalog #: 42558000402 lot #: 63532896, persona partial knee cemented tibia size e right medial catalog #: 42538000502 lot #: 63881381.Report source - foreign: (b)(6).The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The product was evaluated through manufacturing review and the complaint was confirmed through review of medical records.The device history records could were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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.This report was previously submitted erroneously on oct 15, 2019, oct 31, 2019 and mar 24, 2020 under manufacturing report number 0001822565-2019-04431.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 3007963827-2019-00295, 0001825034-2020-01310, 0001825034-2020-01315.

Event Description

It was reported that approximately 1 year post implantation, the patient was treated for pain and instability.Initial operative notes did not identify any intraoperative complications.Attempts have been made and no further information has been provided.

• Brand Name: PERSONA PARTIAL KNEE ARTICULAR SURFACE RIGHT MEDIAL SIZE E 8MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9879978
• MDR Text Key: 189580796
• Report Number: 0001825034-2020-01315
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304818231
• UDI-Public: (01)00880304818231
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 42528200508
• Device Lot Number: 63583930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 109