MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 12 MM HEIGHT; PROSTHESIS, KNEE

Catalog Number	42512100312
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Erythema (1840); Pain (1994); Loss of Range of Motion (2032); Rash (2033); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial left total knee arthroplasty.Subsequently, the patient reported that since surgery has been suffering with ongoing pain, redness, swelling, rash, decreased range of motion, stiffness, and tightness of knee.The patient has consulted an immunologist who is testing her for allergies to the components and bone cement.
Additional Manufacturer Narrative
(b)(4).D10: concomitant medical products: 42572605801: femur cr standard left size 5: 65588780.42532006701: tibia cemented 5 degree stemmed left size d: 66891502.42540000032: all poly patella cemented: 67037346.110034355: refobacin bc r 1x40 us: c0104v07ba.Unknown depuy bone cement x 2.The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental report 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; 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.Medical records and radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the patient developed symptoms consistent with a possible allergic reaction, including redness, pain, swelling, heat, stiffness, and progressively worsening severe pain with markedly limited bending motion and a sensation of tightness around the knee.An immunologist recommended allergy testing of the implant components, as their presentation suggested hypersensitivity.Current management includes monitoring, x-rays, mri, and physical therapy.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 ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 12 MM HEIGHT
• 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 BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23057539
• Report Number: 3007963827-2025-00365
• Device Sequence Number: 12916012
• Product Code: JWH
• UDI-Device Identifier: 00889024235502
• UDI-Public: (01)00889024235502(17)271220(10)65594820
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K193223
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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 Catalogue Number: 42512100312
• Device Lot Number: 65594820
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2023
• 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: Other
• Patient Sex: Female
• Patient Weight: 57 KG