MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL KNEE TIBIAL COMPONENT CEMENTED SIZE F LEFT MEDIAL; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Osteolysis (2377); Swelling/ Edema (4577)

Event Date 10/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant devices - persona partial knee femoral component cemented size 3 left catalog #: 42558000301 lot #: 64234164, persona partial knee articular surface left medial size f 11mm catalog #: 42518200611 lot #: 63082772, unknown refobacin cement catalog #: ni lot #: ni.Report source - foreign: (b)(6).The product was evaluated through manufacturing review and the reported event was confirmed through review of medical records.The device history records 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 jan 5, 2021 and feb 3, 2021 under manufacturing report number 3007963827-2021-00003.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001825034-2021-00346.0001825034-2021-00924.

Event Description

It was reported that the patient underwent a left knee arthroplasty revision to address pain, swelling and tibial osteolysis approximately fifteen (15) months post-operatively.Initial operative notes did not identify any intraoperative complications.Revision operative notes reported removal of implants without bone loss with no loosening identified.New components were implanted and the surgery was completed without complications.Attempts have been made and no additional information is available at this time.

• Brand Name: PERSONA PARTIAL KNEE TIBIAL COMPONENT CEMENTED SIZE F LEFT MEDIAL
• 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: 11586045
• MDR Text Key: 242910935
• Report Number: 0001825034-2021-00923
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304812703
• UDI-Public: (01)00880304812703(17)280831(10)64039053
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42538000601
• Device Lot Number: 64039053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 109