MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA FEMORAL POSTERIOR AUGMENT CEMENTED; PROSTHESIS KNEE

Catalog Number	42556807005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930); Pain (1994); Joint effusion (4849)
Date of Event	12/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient is experiencing fever/body aches, pain, localized joint warmth and swelling twelve days post implantation.On ct imaging a joint effusion with gas collection was demonstrated which was consistent with the presentation of and raised concern for an infected knee arthroplasty.Patient was transferred to his surgical facility for further assessment.No additional details or outcomes have been provided at this time.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
(b)(4).D10 - medical product: 42504607011, lot 66855842 persona revision femur cemented sz 11.42556807005, lot 66395699 persona revision femoral posterior augment cemented, sz 11, 5mm.42560007514, lot 66919946 persona revision stem extension tapered cemented, 14mm +75mm.42556607010, lot 64651272 persona revision femoral distal augment sz 11, 10mm.42545001013, lot 64700938 persona revision tm femoral central cone sz large.42511401012, lot 64254883 persona art surface, 12mm.42512601012, lot 65497107 persona vivacit-e art surface, 12mm.42532008301, lot 65204461 persona cemented tibia, sz.110034355 lot av06de0104 refobacin bone cement r 1x40 (x2).H6: mechanical (g04) - femur.H3: customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
Upon receipt of additional information, it was determined that the initial report was submitted in error and should be voided as this event is not reportable.
Event or Problem Description
Upon receipt of additional information, it was determined that the initial report was submitted in error and should be voided as this event is not reportable.

• Brand Name: PERSONA FEMORAL POSTERIOR AUGMENT CEMENTED
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21909439
• Report Number: 0001822565-2025-01154
• Device Sequence Number: 8729054
• Product Code: JWH
• UDI-Device Identifier: 00889024556942
• UDI-Public: (01)00889024556942(17)340427(10)66615698
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/08/2025

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
• Device Catalogue Number: 42556807005
• Device Lot Number: 66615698
• 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: 03/26/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2024
• 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 H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 147 KG