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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: femur cemented standard catalog # 42504605802 lot # 65120532.Stem extension tapered catalog # 42560007514 lot # 65124728.Femoral distal augment cemented catalog # 42556605805 lot # 65112771.Tibia fixed cemented catalog # 42542006402 lot # 65104607.Articular surface fixed bearing constrained condylar knee (cck) catalog # 42522800416 lot # 64615584.Stem extension tapered cemented catalog # 42560007514 lot # 65124659.Tibial augment cemented catalog # 42555803205 lot # 65042322.Refobacin bc r 1x40 us catalog # 110034355 lot # h2203y07aa.Refobacin bc r 1x40 us catalog # 110034355 lot # z50bak2305.Non zb patella catalog # unk lot # unk.B3, d10 : mar 2023.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.
Event or Problem Description
It was reported the patient experienced an unknown fall.The patient reports pain and stiffness post implantation.The patient was prescribed an additional course of physical therapy which has improved the patient¿s symptoms.No more information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h11.Correction: h4.Reported event was confirmed by review of medical records provided.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Medical records review indicates there is mild pain; stiffness after the fall, and no indication of loosening.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 TIBIAL 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: 19697343
• Report Number: 0001822565-2024-02284
• Device Sequence Number: 8122151
• Product Code: JWH
• UDI-Device Identifier: 00889024557154
• UDI-Public: (01)00889024557154(17)310221(10)64997326
• 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: 2021
• 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): 12/26/2024

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 Model Number: N/A
• Device Catalogue Number: 42555803405
• Device Lot Number: 64997326
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2021
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Race: Black Or African American