MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA TIBIA STEMMED; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	03/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: femur cemented cruciate retaining (cr) catalog # 42502006402 lot # 65594459.Articular surface medial congruent (mc) catalog # 42522100810 lot # 65634264.All-poly patella catalog # 42540200035 lot # 65777311.Headless trocar drill pin catalog # 00590102000 lot # 65701807.2.5 mm female hex screw catalog # 42509902525 lot # 65726727.H3: customer has indicated that the product will not be returned because requested but not returned by hospital.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported patient underwent a revision procedure ten months post implantation due to metal allergy.Attempts to obtain additional information have been made; however, no more is available at this time.
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.
Event or Problem Description
Upon receipt of additional information, it was determined that the initial report was submitted in error and should be voided.It is now verified that the tibial component as the product does not contain nickel.
Additional Manufacturer Narrative
Upon receipt of additional information, it was determined that the initial report was submitted in error and should be voided.It is now verified that the tibial component as the product does not contain nickel.

• Brand Name: PERSONA TIBIA STEMMED
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• 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: 19086489
• Report Number: 3007963827-2024-00107
• Device Sequence Number: 12544698
• Product Code: MBH
• UDI-Device Identifier: 00889024471061
• UDI-Public: (01)00889024471061(17)330105(10)65690974
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2024

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42532007102
• Device Lot Number: 65690974
• 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: 03/17/2024
• Supplement Date Received by Manufacturer: 04/09/2024; 08/20/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 05/02/2024; 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2023
• 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 H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female