MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA ARTICULAR SURFACE MEDIAL CONGRUENT (MC); PROSTHESIS KNEE

Catalog Number	42512100514
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Pain (1994); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: tibia cemented 5 degree stemmed catalog # 42532006401, lot # 64409817.Femur cemented cruciate retaining (cr) catalog # 42502006401, lot # 64440165.All poly patella catalog # 42540000032, lot # 64515365.Stem extension tapered cemented catalog # 42557000114, lot # 64529817.Bone screw self-tapping 6.5 mm dia.25 mm length catalog # 00625006525, lot # 64403730.Bone screw self-tapping 6.5 mm dia.25 mm length catalog # 00625006525, lot # 64484134.Unk cement catalog # unk, lot # unk.H3: customer has indicated that the product will not be returned because it 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 patient is experiencing weakness, imbalance, swelling, and aching in the knee post implantation.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, b5, d8, g3, g6, h2, 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 related to the reported event.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records provided and reviewed state that the patient underwent an initial left total knee arthroplasty on due to osteoarthritis.The procedure was performed using a mid-vastus arthrotomy, with alignment and ligament balancing confirmed intraoperatively, and all implants cemented without intraoperative complications.The implanted components included persona tibial, femoral, patellar, and articular surface components with screws, hybrid stem, and cement.Subsequently, the patient reported ongoing symptoms including weakness, imbalance, swelling, aching, and a sensation of instability in the left knee.The patient has been using an over-the-counter brace for comfort and stability.A revision is being anticipated on an unknown date due to these ongoing symptoms.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 ARTICULAR SURFACE MEDIAL CONGRUENT (MC)
• 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: 22005373
• Report Number: 0001822565-2025-01349
• Device Sequence Number: 7220145
• Product Code: MBH
• UDI-Device Identifier: 00889024469099
• UDI-Public: (01)00889024469099(17)241031(10)64558065
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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
• Device Expiration Date: 10/31/2024
• Device Catalogue Number: 42512100514
• Device Lot Number: 64558065
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2019
• 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 H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 52 KG