MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL ARTICULAR SURFACE LEFT MEDIAL SIZE E 10 MM THICKNESS; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 3007963827-2022-00145.Concomitant medical products: partial tibial cemented size e left medial item# 42538000501, lot# 64201293.Partial femur cemented size 3 left medial item# 42558000301, lot# 64321307.
Event or Problem Description
It was reported that a patient was revised approximately ten months post implantation due to pain and decreased daily activities.Attempts to obtain additional information have been made; however, no more information is available.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, g3, g6, h1, h2, h3, h6, and h10 no product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified patient continue to experience pain and had difficulty walking.To counter this issue, patient was prescribed pain medication and using assistive device while walking.X-ray review shows no issue with patient hardware.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.Per package insert:01501264, pain is known adverse effect of the system.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
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: a4, b4, b5, b7, g3, g6, h1, h2, and h10.
Event or Problem Description
It was reported that a patient was revised approximately ten months post implantation due to ongoing pain and patient comorbidities after gardening.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
Upon reassessment of this event, it was determined this product should not have been reported under this mfr number.This report should be voided, and a corrected report will be filed under mfr 0001825034-2023-00862.
Event or Problem Description
Upon reassessment of this event, it was determined this product should not have been reported under this mfr number.This report should be voided, and a corrected report will be filed under mfr 0001825034-2023-00862.

• Brand Name: PARTIAL ARTICULAR SURFACE LEFT MEDIAL SIZE E 10 MM THICKNESS
• 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: 14469651
• Report Number: 0001822565-2022-01475
• Device Sequence Number: 17285649
• Product Code: HSX
• UDI-Device Identifier: 00880304818194
• UDI-Public: (01)00880304818194(17)231130(10)64222252
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/19/2023

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 Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 42518200510
• Device Lot Number: 64222252
• 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: 05/06/2022
• Supplement Date Received by Manufacturer: 05/16/2022; 06/09/2022; 04/19/2023
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 06/10/2022; 06/15/2022; 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 69 KG