MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA CEMENTED NARROW POSTERIOR STABILIZED FEMORAL COMPONENT SIZE 7; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	03/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right knee arthroplasty revision to address deep, staphylococcus aureus infection approximately one (1) month post-operatively.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
(b)(4).Concomitant devices - persona cemented stemmed tibial component right size e catalog #: 42532007102 lot #: 65199572, persona constrained posterior stabilized articular surface right 14mm catalog #: 42522600714 lot #: 64945522, persona tapered cemented stem extension 14mm diameter +30mm length catalog #: 42557000114 lot #: 65264429, persona cemented all poly patella 32mm catalog #: 42540000032 lot #: 65134405.The complainant has not yet indicated whether the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 3007963827-2022-00155, 3007963827-2022-00157.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: during the investigation process, a review of the sterile certifications were found to be conforming with no applicable deviations.The devices were verified to have gone through acceptable sterilization guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as hospital/surgical environment, provider-related risk factors, and/or patient comorbidities/risk factors.As there were no indications of a product or process issue affecting implant safety or effectiveness, the implanted products were not identified to contribute to the reported infection.Zimmer biomet has determined that this event is no longer reportable based on the aforementioned statements.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 CEMENTED NARROW POSTERIOR STABILIZED FEMORAL COMPONENT SIZE 7
• 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: 14564335
• Report Number: 3007963827-2022-00156
• Device Sequence Number: 17438964
• Product Code: JWH
• UDI-Device Identifier: 00889024228764
• UDI-Public: (01)00889024228764(17)310808(10)65139649
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2022

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: 42500006202
• Device Lot Number: 65139649
• 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: 05/04/2022
• Supplement Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2021
• 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 Age: 69 YR
• Patient Sex: Female