MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	42512400511
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Item# 42532006401; lot# 66420528.G2: foreign - event occurred in japan.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.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
It was reported that a total knee arthroplasty was performed with persona and the surgeon was unable to mate the articular surface to the tibial plate.After removing it for cleaning and confirming that there were no inclusions on the tibial plate, he inserted the articular surface, but the lateral side didn't seat properly.As a result, the surgery was completed with another articular surface with a different lot number.Attempts have been made and no further event information is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; d9; g1; g3; g6; h1; h2; h3; h6 visual inspection of the returned device found the distal surface to exhibit damage and the locking features to be flared out.Medical records were not provided.Review of the device history record identified no related deviations or anomalies during manufacturing.Root cause cannot be determined.Complaint is confirmed via product evaluation.If any further information 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: ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED
• 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: 19370802
• Report Number: 3007963827-2024-00194
• Device Sequence Number: 7724641
• Product Code: MBH
• UDI-Device Identifier: 00889024237094
• UDI-Public: (01)00889024237094(17)280829(10)66020244
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 42512400511
• Device Lot Number: 66020244
• Was Device Available for Evaluation?: Yes
• 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: 05/02/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H11.
• Patient Sex: Prefer Not To Disclose