MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL KNEE CEMENTED FEMORAL COMPONENT SIZE 2 LEFT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source - foreign: (b)(6).Concomitant devices - persona partial knee articular surface left medial size d 10mm catalog #: 42518200410 lot #: 64559086, persona cemented partial knee tibial component size d left catalog #: 42538000401 lot #: 64562617.The product was evaluated through review of sterilization records, however, the reported event could not be confirmed.Sterile certifications were reviewed and found to be conforming with no deviations identified and the devices were verified to have undergone acceptable sterilization processes 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 hospital/surgical environment, provider-related risk factors, and/or patient comorbidities/risk factors.As there were no indications of product or process issues affecting implant safety or effectiveness, the implanted products were not identified as the source or contributing to the reported infection.The root cause could not be traced to the device(s).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 on nov 4, 2020 under manufacturing report number 3007963827-2020-00294.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001825034-2020-04000.0001825034-2021-00930.
Event or Problem Description
It is reported that the patient underwent a left knee arthroplasty revision of the articular surface to address infection eighteen (18) days postoperatively.The infection did not resolve and an additional articular surface revision was performed sixteen (16) following the first revision.Attempts have been made and no additional information is available.

• Brand Name: PERSONA PARTIAL KNEE CEMENTED FEMORAL COMPONENT SIZE 2 LEFT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11588128
• Report Number: 0001825034-2021-00929
• Device Sequence Number: 20054092
• Product Code: HSX
• UDI-Device Identifier: 00880304808454
• UDI-Public: (01)00880304808454(17)290831(10)64415111
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2021

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: 42558000201
• Device Lot Number: 64415111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention