MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA 0A SPIKED KEEL RIGHT SIZE E OSSEOTI TIBIA; PROSTHESIS, KNEE

Catalog Number	42535007102
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 42508006402, cruciate retaining right size 8 pps narrow femur, lot#: 66795369.42522100810, articular surface medial congruent (mc) right 10 mm height use with tibia sizes e-f/cr femur sizes 8-11, lot#: 66837560.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device 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 that approximately 6 months post implantation of a right total knee arthroplasty, the patient began experiencing pain, alluding to possible nickel and/or chromium allergies.Patient had a blood test performed that identified nickel allergy and a patch test that was positive for chromium allergy, but nickel did not appear on the patch test.At this time, no medical intervention has been performed and devices remain implanted.Attempts for additional information have been made and all has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, h2, h6 the reported event was unable to be confirmed due to lack of medical records.No product was received, therefore visual and dimensional evaluations could not be made.Review of the device history records was not performed for this device as per the ifu, it does not contain nickel or chromium, the elements the patient reported to be allergic to.The root cause is attributed to no problem found due to device not containing these elements.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional information to report at this time.

• Brand Name: PERSONA 0A SPIKED KEEL RIGHT SIZE E OSSEOTI TIBIA
• 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: 23572942
• Report Number: 3007963827-2025-00460
• Device Sequence Number: 10233334
• Product Code: JWH
• UDI-Device Identifier: 00889024631939
• UDI-Public: (01)00889024631939(17)341113(10)67018611
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K221479
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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: 42535007102
• Device Lot Number: 67018611
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2024
• 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: Unknown