MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE FIXED BEARING PS RIGHT 16 MM HEIGHT; PROSTHESIS, KNEE

Catalog Number	42522400816
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	06/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: femur cemented posterior stabilized (ps) standard right size 11: catalog#42500607002, lot#65423934; tibia cemented 5 degree stemmed right size f: catalog#42532007502, lot#65417548; all-poly patella cemented 38 mm diameter: catalog#42540200038, lot#65960834; unknown palacos cement: catalog#ni, lot#ni.The product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported via a clinical study that a patient underwent an initial total knee arthroplasty.Approximately six (6) weeks post-implantation, the patient reported increased pain, lack of range of motion, swelling, and effusion.Subsequently, the patient underwent an irrigation and debridement procedure with an exchange of the polyethylene bearing due to deep infection.The procedure was completed without complication and the patient is reportedly doing well at one-year post-operation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The device history records were not reviewed as the event was determined to be unrelated to the implanted zimmer biomet device.During the investigation process, the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there were no indications of product or process issues identified affecting implant safety or effectiveness, the implanted products are not identified as the source or contributing to the reported infection.The root cause was determined to be traced to non-device related factors.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.

• Brand Name: PERSONA ARTICULAR SURFACE FIXED BEARING PS RIGHT 16 MM HEIGHT
• Common Device Name: 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: 19703100
• Report Number: 3007963827-2024-00260
• Device Sequence Number: 20751665
• Product Code: MBH
• UDI-Device Identifier: 00889024243880
• UDI-Public: (01)00889024243880(17)250630(10)64649825
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2024

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: 06/30/2025
• Device Catalogue Number: 42522400816
• Device Lot Number: 64649825
• 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: 06/10/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2020
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Race: White