MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA ARTICULAR SURFACE FIXED BEARING (PS) RIGHT 12MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	07/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient began to experience pain, warmth, effusion, and decreased range of motion about three years two months post implantation and an aspiration of the synovial fluid was completed.Three days later the patient underwent an i&d, with poly exchange, for a periprosthetic infection without complication.After completing iv and oral antibiotics, the patient began to experience pain, swelling, limited range of motion, and difficulty ambulating.Eight months after the i&d, an aspiration was completed and the culture results indicated an ongoing infection related to staph epidermitis.Subsequently, the patient underwent the first stage of a two stage revision where all implants were removed and a temporary spacer was implanted.Approximately two months later, the patient underwent the second stage revision where moderate osteolysis was noted around the tibial and femoral components that was consistent with the previous infection/explantation and a revision knee system was implanted without complication.
Additional Manufacturer Narrative
(b)(4).The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products(reported).42500606802 persona femoral sz 10 rt- cemented lot# 63629202.42532007902 persona tibia 5 sz g rt- cemented lot# 63621645.42521401012 persona art surface 12mm lot# 64535690.42557000114 persona tibial stem extension 14mm +30mm- cemented lot# 63693052.42540000038 all poly patella sz 38x9.9mm- cemented lot# 63689686.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g3, g6, h1, h2, h3, h6, h10, h11 it was reported that a patient required a two-stage revision due to recurrent infection which also caused pain, range of motion loss, and bone loss/breakdown (osteolysis).During the investigation process a review of 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 are no indications of a product or process issues identified affecting implant safety or effectiveness, implanted products are not identified as the source or contributing to the reported infection.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.

• Brand Name: PERSONA ARTICULAR SURFACE FIXED BEARING (PS) RIGHT 12MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19668409
• Report Number: 0002648920-2024-00222
• Device Sequence Number: 6836260
• Product Code: JWH
• UDI-Device Identifier: 00889024643536
• UDI-Public: (01)00889024643536(17)240531(10)63379063
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• 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): 12/18/2024

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: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 42521401012
• Device Lot Number: 63379063
• 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: 06/14/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 12/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2016
• 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: 136 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White