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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: unk persona bearing catalog # unk lot # unk; unk persona tibia catalog # unk lot # unk.Multiple mdr reports were filled for this event: 0001822565-2024-00054; 0001822565-2024-00059.H6: suggested component code: mechanical (g04) - femur reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.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.H3 other text : remains implanted.
Event or Problem Description
It was reported patient is experiencing unknown ongoing chronic problems post implantation.The patient alleges to be meeting with a surgeon for further care; however, no further intervention has been reported to date.Attempts to obtain additional information have been made; however, no more is available.
Event or Problem Description
It was reported that the patient had nerve ablations performed due to chronic problems post implantation.The patient is planning a left knee revision surgery, no revision procedure has been reported to date.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.D10 - medical product: articular surface fixed bearing constrained posterior stabilized (cps) catalog # 42512600712 lot # 64556743.Tibia trabecular metal two-peg porous fixed bearing catalog # 42530007101 lot # 64202289 standard primary patella catalog # 00587806532 lot # 64296443.
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.H6: insufficient information available and no findings available is n/a which was reported on initial report.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Additional information does not affect the root cause medical records review indicates that patient is meeting with an orthopaedic surgeon due to continuing and ongoing chronic problems with the zimmer, biomet persona knee systems installed now.Both knee nerve ablations.Left knee revision surgery to be scheduled after next right knee surgery.This event is for pain and is considered a serious injury as illness or impairment which requires hospitalisation, medical intervention and/or surgical intervention has occurred.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 FEMUR 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: 18451182
• Report Number: 0001822565-2024-00058
• Device Sequence Number: 18087964
• Product Code: JWH
• UDI-Device Identifier: 00889024562691
• UDI-Public: (01)00889024562691(17)300531(10)64683455
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K181947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2024

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: 42504606211
• Device Lot Number: 64683455
• 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: 12/08/2023
• Supplement Date Received by Manufacturer: 04/30/2024; 09/13/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 05/22/2024; 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2020
• 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: Other
• Patient Sex: Female