MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TRABECULAR METAL TWO-PEG POROUS TIBIAL COMPONENT LEFT SIZE E; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577); Radiolucent Lines (4848); Aseptic loosening (4883)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona posterior stabilized articular surface left 10mm catalog #: 42512400710, lot #: 65355286, persona posterior stabilized narrow porous femoral component catalog #: 42500206401, lot #: 64556329r, persona cemented all-poly patella 35mm catalog #: 42540200035, lot #: 65178906.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.
Event or Problem Description
It was reported that the patient is experiencing tibial component loosening approximately two (2) years and seven (7) months following left knee arthroplasty.No medical intervention has been reported to date.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b1, b2, b4, b5, g2, g3, g6, h1, h2, h6, h11.
Event or Problem Description
It was reported that the patient is experiencing pain, swelling, instability and immobility with tibial component loosening and tibial peg radiolucency approximately two (2) years and seven (7) months following left knee arthroplasty.A revision surgery has been planned to revise the knee.Attempts have been made, however, no additional information is available.
Event or Problem Description
No additional information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, h2, h3, h6.The following section was corrected: h4.The reported event was unable to be confirmed.No devices or photographs were received; visual examinations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.No medical records were provided.A definitive root cause could not 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.

• Brand Name: PERSONA TRABECULAR METAL TWO-PEG POROUS TIBIAL COMPONENT LEFT SIZE E
• 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: 21923469
• Report Number: 0001822565-2025-01176
• Device Sequence Number: 8623542
• Product Code: MBH
• UDI-Device Identifier: 00889024510555
• UDI-Public: (01)00889024510555(17)320707(10)65462613
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K173417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42530007101
• Device Lot Number: 65462613
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 05/14/2025; 06/23/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 06/09/2025; 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown