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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant devices: persona partial cemented femoral component right medial size 3 catalog #: 42558000302, lot #: 63760813; persona partial articular surface right medial size e 8mm catalog #: 42528200508, lot #: 63449777.Report source - foreign: (b)(6).The product was evaluated through manufacturing review, however, the reported event could not be confirmed.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 under manufacturing report number 0001822565-2018-05938.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001825034-2020-02037, 0001825034-2020-02039.
Event or Problem Description
It was reported that patient reported ongoing pain one (1) year following right knee arthroplasty and was given cocodamol for treatment of pain.The patient later underwent an arthroscopic procedure approximately twenty (20) months post-operatively to address the knee pain that had not yet resolved.Attempts have been made and no additional information is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, b5, g3, g6, h2, h6, h11.The following sections were corrected: d4, h4.The root cause remains undetermined.However, the reported event was determined to not be a serious injury, as the patient's symptoms are attributed to disease progression over time.As zimmer biomet does not have any devices that are meant to cure and/or prevent progression of pre-existing patient diseases, zimmer biomet does not consider this an mdr-reportable event.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 or Problem Description
It was reported that patient reported ongoing pain and swelling one (1) year following right knee arthroplasty and was given a pain-reliever for treatment of pain.The patient later underwent an arthroscopic procedure approximately twenty (20) months post-operatively to address the knee pain that had not yet resolved.The patient is on a waiting list to undergo patella resurfacing for treatment of anterolateral patello-femoral wear/progression of arthritis to resolve the patient's ongoing symptoms.Attempts have been made and no additional information is available at this time.

• Brand Name: PERSONA PARTIAL CEMENTED TIBIAL COMPONENT RIGHT MEDIAL SIZE E
• Common Device Name: 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: 10072483
• Report Number: 0001825034-2020-02038
• Device Sequence Number: 14423373
• Product Code: HSX
• UDI-Device Identifier: 00880304812697
• UDI-Public: (01)00880304812697(17)270430(10)63632020
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42538000502
• Device Lot Number: 63632020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 86 KG