MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA CRUCIATE RETAINING STANDARD FEMORAL COMPONENT RIGHT SIZE 10; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646)
Date of Event	05/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona 0° keel cemented tibial component right size f catalog #: 42536007502 lot #: 66114025, 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 h6 - component code - proposed code is mechanical (g04) - femur.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 the reported event.The device history records were reviewed and no discrepancies were identified.A definitive root cause for the femoral loosening 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 CRUCIATE RETAINING STANDARD FEMORAL COMPONENT RIGHT SIZE 10
• 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: 23604786
• Report Number: 0001822565-2025-04249
• Device Sequence Number: 13221832
• Product Code: JWH
• UDI-Device Identifier: 00889024631366
• UDI-Public: (01)00889024631366(17)330218(10)65754645
• 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: 42508606802
• Device Lot Number: 65754645
• 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: 02/21/2023
• 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