MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA 0° KEEL CEMENTED TIBIAL COMPONENT RIGHT SIZE F; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Use of Device Problem (1670); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Radiolucent Lines (4848); Aseptic loosening (4883)
Date of Event	05/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona cruciate retaining standard femoral component right size 10 catalog #: 42508606802, lot #: 65754645, persona medial congruent articular surface right 11mm catalog #: 42522100811, lot #: 66084835, nexgen trabecular metal standard primary patella catalog #: 00587806541, lot #: 66068260.The complainant has indicated that the product will not be returned to zimmer biomet for investigation.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 during knee arthroplasty that the surgeon implanted a cemented tibial tray without cement while under the impression that the device was a press-fit implant.The error was not identified until after implantation, but the surgeon did not opt to revise the implant at that time.Subsequently, the patient was revised approximately five (5) months later to address pain and loosening.During the procedure, the tibial component was noted to be loose with no cement on the cemented tray.The femoral component was also identified to be loose with no bone ingrowth.All components were revised without complication.Initial operative notes noted no intraoperative complications and the patient tolerated the procedure well.Revision operative notes noted that both the tibial and femoral components were loose.All components were revised and no intraoperative complications were noted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, g3, g6, h2, h10, h11.The following sections were corrected: e1.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.The following sections were corrected: h4.The product was evaluated through manufacturing review and medical records provided confirmed that the cemented tibial component was implanted without cement and later revised due to loosening.The device history records were reviewed and no discrepancies were identified.Per the instructions for use "porous coated components may be used cemented or uncemented (biological fixation), except for the persona osseoti keel tibia which is for uncemented use only.All other femoral, tibial baseplate and all-polyethylene (uhmwpe and vehxpe) patella components are indicated for cemented use only." therefore, the root cause is attributed to failure to follow instructions.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 0° KEEL CEMENTED TIBIAL COMPONENT RIGHT SIZE F
• 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: 23604795
• Report Number: 0001822565-2025-04250
• Device Sequence Number: 15912923
• Product Code: JWH
• UDI-Device Identifier: 00889024632134
• UDI-Public: (01)00889024632134(17)331015(10)66114025
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K221479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2026

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 42536007502
• Device Lot Number: 66114025
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 12/22/2025; 04/20/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 01/14/2026; 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2023
• 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; Hospitalization
• Patient Sex: Male
• Patient Weight: 108 KG