MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC); PROSTHESIS KNEE

Catalog Number	42522200511
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Swelling/ Edema (4577)
Date of Event	01/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: persona femur cemented cruciate retaining (cr) catalog # 42572606202 lot # 65123721.Persona all poly patella catalog # 42540000032 lot # 65140199.Tibia cemented catalog # 42532007102 lot # 65046974.Unk bone 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 was experiencing pain, stiffness, and swelling two years post-op post implantation for which physical therapy has been prescribed.Attempts to obtain additional information have been made; however, no more is available at this time.
Event or Problem Description
It was reported patient was experiencing pain, stiffness, and swelling with concern for scar tissue involvement two years post-op post implantation for which physical therapy has been prescribed.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.
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; g3; g6; h1; h2; h3; h6; h10; h11.Product has not been returned.No product evaluation was able to be completed.Root cause of the reported event is not device related.Postoperative joint swelling is a localized swelling or inflammation which is described as an accumulation of fluid in the interstitium, the space between cells, located beneath the skin and in cavities of the body.Inflammation from surgical trauma causes the release of moderators called cytokines.Swelling may increase during activities or when sitting or standing in one position for an extended period.Swelling or inflammation is the body¿s natural response to heal damaged tissue postoperatively.According to the aaos, mild to moderate swelling is a normal and expected finding for three to six months following surgery.Severe swelling is not considered an expected finding and is indicative of an underlying complication.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.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.

• Brand Name: PERSONA ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC)
• Common Device Name: PROSTHESIS KNEE
• 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 ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21882644
• Report Number: 3007963827-2025-00159
• Device Sequence Number: 12675993
• Product Code: MBH
• UDI-Device Identifier: 00889024243040
• UDI-Public: (01)00889024243040(17)251124(10)64842916
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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,Followup
• Report Date (Section B): 08/11/2025

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/24/2025
• Device Catalogue Number: 42522200511
• Device Lot Number: 64842916
• 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: 03/28/2025
• Supplement Date Received by Manufacturer: 04/23/2025; 08/06/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 05/13/2025; 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Race: White