MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA FEMUR TRABECULAR METAL POSTERIOR STABILIZED (PS); 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	Failure of Implant (1924); Pain (1994); Insufficient Information (4580)
Date of Event	11/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: unk persona bearing catalog # unk lot # unk.Unk persona tibial catalog # unk lot # unk.H3: customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565-2024-00003 h3 other text : product location unknown.
Event or Problem Description
It was reported patient underwent a revision procedure fourteen months post implantation due to instability.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
Reported event was unable to be confirmed due to limited information received from the customer.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.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.
Event or Problem Description
It was reported patient underwent a revision procedure fifteen months post implantation due to pain and instability.During the revision, the surgeon noted that the distal femoral refresher cut of 5mm was consistent with a diagnosis of flexion instability.The femoral component and art surface were replaced which resolved the complication, and the tibial and patellar components remained intact and well-fixed.Attempts to obtain additional information have been made; however, no more is available at this time.
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: persona articular surface fixed bearing posterior stabilized (ps) catalog # 42512400710 lot # 64249069.Nexgen standard primary patella catalog # 00587806532 lot # 64296443 tibia trabecular metal two-peg porous fixed bearing left size e catalog # 42530007101 lot # 64202289.
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.Reported event was confirmed by review of medical records provided.Additional information does not affect the root cause.Medical records review indicates that the patient presented with recurring pain and flexion instability, femoral component and art surface were removed.Tibial and patellar components were well fixed and left intact.Distal femoral cut freshened by 5mm consistent with flexion instability diagnosis.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 TRABECULAR METAL POSTERIOR STABILIZED (PS)
• 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: 18437104
• Report Number: 0001822565-2024-00002
• Device Sequence Number: 18050473
• Product Code: MBH
• UDI-Device Identifier: 00889024469716
• UDI-Public: (01)00889024469716(17)260430(10)63348668
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K122745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/29/2024

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 Expiration Date: 04/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 42500206401
• Device Lot Number: 63348668
• 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: 12/08/2023
• Supplement Date Received by Manufacturer: 02/21/2024; 04/30/2024; 10/25/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 02/23/2024; 05/21/2024; 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2016
• 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: Unknown
• 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: Required Intervention; Hospitalization
• Patient Sex: Female