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

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Insufficient Information (4580)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: unk persona bearing catalog # unk lot # unk.Unk persona tibial tray catalog # unk lot # unk.Multiple mdr reports were filled for this event: 0001822565-2024-00060.0001822565-2024-00062.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 on the right knee.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.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.Unknown persona bearing 14mm cck item # unk lot # unk.Standard primary patella item # 00587806532 lot # 64227886.Bone cement item # unk lot # e2703z20ca.Bone cement item # unk lot # 005eae2407.Bone cement item # unk lot # f2702z12ca.Stem extension item # unk lot # 64859495.Tibia e item # unk lot # 64804179.Tibial cone xs item # unk lot # 64815920.Stem extension item # unk lot # 64925236.Lateral tibial augment item # unk lot # 64826750.Medial tibial augment item # unk lot # 64817484.Art surface cps 12mm item # unk lot # 64214783.Cancellous bone graft item # unk lot # unk.
Event or Problem Description
It was reported patient had nerve ablations in the knee with recurrent pain and instability causing falls three years post implantation.Patient is scheduled a right knee revision surgery, no revision procedure has been reported to date.Patient had multiple knee aspirations and both knee nerve ablations.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: insufficient information available and no findings available is n/a which was reported on initial report.Additional information does not affect the root cause medical records review indicates there is multiple knee aspirations, both knee nerve ablations (pain), hospitalized for infection for 1 week, had to have 28 teeth removed before knee replacement surgery ¿ indicates a dental infection rather than knee infection; therefore, no complaint / category at this time., shoulder surgery due to right knee giving out and falling, right knee revision surgery (b)(6) 2024 - scheduled.This event is for pain and instability and is considered a serious injury as illness or impairment which requires hospitalization, 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: 18452187
• Report Number: 0001822565-2024-00061
• Device Sequence Number: 20621751
• Product Code: JWH
• UDI-Device Identifier: 00889024562707
• UDI-Public: (01)00889024562707(17)301115(10)64867254
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42504606212
• Device Lot Number: 64867254
• 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; 10/02/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 05/22/2024; 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2020
• 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