MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 10 MM HEIGHT; PROSTHESIS, KNEE

Catalog Number	42522100510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Fall (1848); Hyperextension (4523)
Date of Event	01/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported in a journal article that 2 patients underwent an initial knee surgery and subsequently experienced a fall of an unknown cause resulting in wound dehiscence and hyperextension injuries.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: unknown - unknown persona femoral component - unknown.Unknown - unknown persona tibial component - unknown.G2: journal article citation: nakasone, c., weber, i., israelite, c., & cholewa, j.(2025).Early radiographic evaluation of an anatomic porous tantalum tibia: a prospective, multi-center, non-randomized clinical study.The knee, 53, 264¿272.Https://doi.Org/10.1016/j.Knee.2025.01.010.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: b2; b4; b5; d1; d2; d4; d6a; d10; e1; g1; g2; g3; g4; g6; h1; h2; h4; h6.D10: 42502206602 - femur trabecular metal cruciate retaining (cr) narrow porous - 64071419.42530006702 - tibia trabecular metal two-peg porous fixed bearing right size d - 64407569.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was further reported that approximately 2 weeks post-op, a patient had fallen directly onto the knee causing wound dehiscence.The cause of the fall is unknown.Subsequently, the patient underwent an i&d with a poly exchange and a repair of the muscle, fascia and skin on an unknown date.The patient was then placed into a brace for one month and the patient's symptoms resolved.Attempts have been made and all available information has been provided.
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: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6.The event cannot be 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.Medical records were not provided.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4, b5, d2, g1, g3, g6, h1, h2, h11.H1: this mdr is being submitted as a part of a retrospective literature mdr reporting review and remediation effort based on mdr reporting process and fda adverse event reporting requirement.Capa -07984 was opened on feb 27, 2026, to address corrections.Device performance and/or risk profile are not impacted.If any further information 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) RIGHT 10 MM HEIGHT
• 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: 22326987
• Report Number: 0001822565-2025-02104
• Device Sequence Number: 8429731
• Product Code: MBH
• UDI-Device Identifier: 00889024468177
• UDI-Public: (01)00889024468177(17)241231(10)64558092
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K150090
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/06/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2024
• Device Catalogue Number: 42522100510
• Device Lot Number: 64558092
• 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: 06/09/2025
• Supplement Date Received by Manufacturer: 06/24/2025; 10/16/2025; 04/06/2026
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/15/2025; 10/17/2025; 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2020
• 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: Required Intervention; Hospitalization; Other
• Patient Sex: Unknown