MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REVISION TIBIAL AUGMENT CEMENTED HALF BLOCK RIGHT MEDIAL SIZE EF 5 MM; PROSTHESIS, KNEE

Catalog Number	42555805405
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Loss of Range of Motion (2032)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: femur cemented standard right size 11: catalog#42504607002, lot#64900889; stem extension straight splined uncemented 11 mm diameter +135 mm length: catalog#42560113511, lot#65047323; femoral posterior augment cemented size 11, 5 mm thickness: catalog#42556807005, lot#64982096; femoral distal augment cemented size 11, 11+ 5 mm thickness: catalog#42556607005, lot#65263644, qty#2; tibia fixed cemented right size f: catalog#42542007502, lot#65906026; stem extension straight splined uncemented 14 mm diameter +135 mm length: catalog#42560113514, lot#65042539; all-poly patella cemented 38 mm diameter: catalog#42540200038, lot#66160332; articular surface fixed bearing constrained condylar knee (cck) right 16 mm height: catalog#42522800816, lot#64751925.G2: foreign: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation per hospital policy.The investigation is in process.Upon completion of the investigation, a follow-up mdr be submitted.
Event or Problem Description
It was reported that a patient underwent a right total knee arthroplasty.Approximately six (6) months post-implantation, the patient began to experience a loss of range of motion and an infection was suspected.Subsequently, the patient underwent revision surgery where loosening was found however the infection results were inconclusive.All components were revised without complication.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h6; h10; h11.Visual inspection of the provided images showed femoral and tibial components along with stem components.Devices show heavy residue upon them.As device was not returned, further analysis could not be performed.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause related to the loosening and range of motion concerns was unable to be determined.Investigation results concluded that the root cause of the reported infection is not device related as the sterile certifications were reviewed and found to be conforming with no applicable deviations.Reported event was unable to be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information at time of this report.

• Brand Name: PERSONA REVISION TIBIAL AUGMENT CEMENTED HALF BLOCK RIGHT MEDIAL SIZE EF 5 MM
• 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: 20227488
• Report Number: 0001822565-2024-02959
• Device Sequence Number: 16985420
• Product Code: JWH
• UDI-Device Identifier: 00889024557192
• UDI-Public: (01)00889024557192(17)330206(10)65727065
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 42555805405
• Device Lot Number: 65727065
• 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: 08/20/2024
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male