MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA STEM EXTENSION TAPERED CEMENTED; PROSTHESIS KNEE

Catalog Number	42557000114
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
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
(b)(4).D10 - medical product: articular surface medial congruent (mc) catalog # 42512100514 lot # 64558065, 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.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.H6: mechanical (g04) - stem.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.
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 complaint history identified additional similar complaints for the reported item and no additional complaints for 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 STEM EXTENSION TAPERED CEMENTED
• 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: 22005377
• Report Number: 0001822565-2025-01350
• Device Sequence Number: 20638170
• Product Code: JWH
• UDI-Device Identifier: 00889024247734
• UDI-Public: (01)00889024247734(17)291130(10)64529817
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K181947
• 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 Catalogue Number: 42557000114
• Device Lot Number: 64529817
• 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: 11/13/2019
• 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