MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REVISION CEMENTED TIBIAL COMPONENT RIGHT SIZE D; 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); Radiolucent Lines (4848)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced pain and stiffness approximately two (2) years following right knee arthroplasty.The patient was referred to pain management clinic and reportedly improved.No plan for surgical intervention was reported.Initial operative notes noted no intraoperative complications.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona revision cemented standard femoral component right size 7 catalog #: 42504606202 lot #: 64998934, persona revision cemented tapered stem extension 14mm diameter +75mm length catalog #: 42560007514 lot #: 64853528, persona revision cemented distal femoral augment size 7, 7+ 5mm catalog #: 42556606205 lot #: 64739702, persona posterior stabilized articular surface right 20mm catalog #: 42522600520 lot #: 64104257, persona revision cemented tapered stem extension 14mm diameter +75mm length catalog #: 42560007514 lot #: 64853528, persona revision cemented tibial augment half block right medial size cd 5mm catalog #: 42555803405 lot #: 64925229, persona revision cemented tibial augment half block right medial size cd 10mm catalog #: 42555803210 lot #: 64729302, refobacin bone cement r 1x40 us catalog #: 110034355 lot #: az34al0105 the complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h4, h6, h11.Medical records provided confirmed mild pain and stiffness with minor radiolucency.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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 REVISION CEMENTED TIBIAL COMPONENT RIGHT SIZE D
• 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: 19709197
• Report Number: 0001822565-2024-02311
• Device Sequence Number: 14246978
• Product Code: JWH
• UDI-Device Identifier: 00889024562875
• UDI-Public: (01)00889024562875(17)310419(10)65000266
• 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): 12/16/2024

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: 42542006702
• Device Lot Number: 65000266
• 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: 07/10/2024
• Supplement Report FDA Received Date: 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2021
• 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
• 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 H11 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 117 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American