MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA FEMORAL POSTERIOR AUGMENT CEMENTED SIZE 9, 9+ 10MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Bone Fracture(s) (1870); Pain (1994); Radiolucent Lines (4848)
Date of Event	01/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient had an initial left total knee arthroplasty followed by a revision 7 months later due to tibial and femoral instability.Subsequently, 6 months after the revision the patient was experiencing anterior knee pain and found radiolucency on radiographic imaging.A few months later, the patient had an episode of pain and stiffness and continued to display radiolucency at the 2 year follow-up.Patient reports distal thigh pain with a possible stress fracture and was told to wear a brace.At this time, no surgical intervention has been reported and all implants remain in place.
Additional Manufacturer Narrative
(b)(4).Customer 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 associated products(reported).(b)(6); persona femur cemented plus left size 9+ lot# 64849842.(b)(6); persona stem extension tapered cemented 14mm dia 75mm lot# 65085688.(b)(6); persona femoral distal augment cemented size 9, 9+ 5mm lot# 64728939.(b)(6); persona femoral distal augment cemented size 9, 9+ 5mm lot# 64804858.(b)(6); persona femoral posterior augment cemented size 9, 9+ 5mm lot# 64826733.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g3, g6, h1, h2, h3, h6, h10, h11.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: anterior knee pain; mild stiffness; radiolucency; possible femoral stress fracture.This complaint has been confirmed by review of the provided medical records.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: b4, b5, d5, g3, g6, h1, h2, h6, h11.The updated investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported a patient had an initial left total knee arthroplasty followed by a revision 7 months later due to tibial and femoral instability.Subsequently, 6 months after the revision the patient was experiencing anterior knee pain and found radiolucency on radiographic imaging.A few months later, the patient had an episode of pain and stiffness and continued to display radiolucency at the 2 year follow-up.Patient reports distal thigh pain with a possible stress fracture and was told to wear a brace.Has continued to display radiolucency at the three year follow-up and at the four year follow-up displayed findings of heterotopic ossification on radiographic imaging.At this time, no surgical intervention has been reported and all implants remain in place.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Medical records were provided and reviewed by a healthcare professional.Review of primary operative notes found no intra operative complications.Additionally medical records state that patient was experiencing pain, stiffness, radiolucency, possible femoral stress fracture.Additional notes received states x-rays show heterotopic ossification.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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 FEMORAL POSTERIOR AUGMENT CEMENTED SIZE 9, 9+ 10MM
• 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: 19536906
• Report Number: 0001822565-2024-01990
• Device Sequence Number: 17748592
• Product Code: JWH
• UDI-Device Identifier: 00889024557000
• UDI-Public: (01)00889024557000(17)310316(10)65042302
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup,Followup
• Report Date (Section B): 12/10/2025

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 42556806610
• Device Lot Number: 65042302
• 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: 05/20/2024
• Supplement Date Received by Manufacturer: 11/13/2024; 07/17/2025; 12/10/2025
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 11/22/2024; 08/12/2025; 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2021
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White