MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA FEMORAL DISTAL AUGMENT CEMENTED SIZE 11; PROSTHESIS, KNEE

Catalog Number	42556607005
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Pain (1994); Numbness (2415); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577); Crepitus (4893)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right knee surgery.Subsequently, the patient has reported experiencing pain, crepitus, numbness, swelling, and ambulation difficulties in the post-op period and alleges malalignment of components.They take prescribed medication daily but otherwise no known treatment or additional intervention has occurred to this point.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 42504607002 - femur cemented standard right size 11 - 67134322.42560007514 - stem extension tapered cemented 14 mm diameter +75 mm length - 67076582.42542007902 - tibia fixed cemented right size g stem extension use required - 66774948.42560007514 - stem extension tapered cemented 14 mm diameter +75 mm length - 67053363.42545000510 - tibial central cone size x-small - 65915015.42555807205 - tibial augment cemented half block right lateral size gh 5 mm thickness - 64882739.42555807405 - tibial augment cemented half block right medial size gh 5 mm thickness - 64853497.42522601010 - articular surface fixed bearing constrained posterior stabilized (cps) right 10 mm height use with tibia sizes g-h / ps femur sizes 10-12 - 66153674.42540000035 - all poly patella cemented 35 mm diameter - 66939408.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h4; h6; h10.The event is confirmed.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.X-rays were provided and were reviewed by a healthcare professional.Review of the records states that there is mild malalignment approximately 3 degrees varus positioning and 0 degrees posterior slope with mild overhang posterolateral.There was radiolucency seen along femoral and tibial components.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 DISTAL AUGMENT CEMENTED SIZE 11
• 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: 23567831
• Report Number: 0001822565-2025-04135
• Device Sequence Number: 9859901
• Product Code: JWH
• UDI-Device Identifier: 00889024556751
• UDI-Public: (01)00889024556751(17)321008(10)65597130
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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 Catalogue Number: 42556607005
• Device Lot Number: 65597130
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 84 KG