MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA MC VE ASF L 12MM 8-11/GH; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL

Catalog Number	42512100912
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Arthrofibrosis (4885)
Date of Event	09/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient required manipulation under anesthesia of the left knee approximately 12 weeks post implantation due to arthrofibrosis; all implants were retained.Diligence is in progress regarding this event; to date all available information has been provided.
Additional Manufacturer Narrative
Cmp-(b)(4).D10: medical product: psn fem cr pps ccr nrw sz8 l: catalog#42508006401, lot#66919226; spiked keel left size e osseoti tibia: catalog#42535007101, lot#67234505; 35mm diameter 9.5mm thickness osseoti porous 3-peg patella: catalog#42540500035, lot#66953449.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; b7; e1; e2; e3; g2; g3; h2; h6; h10; h11.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device; therefore, a review of the device history records was not performed.Review of the reported event by a healthcare professional identified the following: arthrofibrosis is defined as the development of fibrous scar tissue within or surrounding a joint.Arthrofibrosis is a known postoperative procedure related complication that can occur from surgical implantation of new joint replacement as well as from previous injuries or surgical procedures.Scar tissue formation is a normal healing response; however, the buildup of such can result in pain, stiffness, limited range of motion, and difficulty properly ambulating.If excess scar tissue develops, conservative measures such as exercises or physical therapy would be attempted first.If these attempts fail, surgical intervention such as manipulation under anesthesia, arthroscopic arthrolysis, or open arthrotomy would become necessary to remove the fibrous tissue and restore joint function.Investigation results concluded that the root cause of the reported event is attributed to non-device related factors.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
It was reported that the patient required manipulation under anesthesia of the left knee approximately 12 weeks post implantation due to arthrofibrosis and loss of range of motion.All implants were retained.It was reported that the patient had poor progression of symptom improvement due to non-compliance following the procedure.Corticosteroids and continued physical therapy were prescribed.

• Brand Name: PERSONA MC VE ASF L 12MM 8-11/GH
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24233285
• Report Number: 3007963827-2026-00037
• Device Sequence Number: 15748967
• Product Code: MBH
• UDI-Device Identifier: 00889024469396
• UDI-Public: (01)00889024469396(17)280728(10)65940404
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K150090
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

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 Catalogue Number: 42512100912
• Device Lot Number: 65940404
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2023
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Hispanic
• Patient Race: White