MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REVISION ARTICULAR SURFACE FIXED BEARING CCK LEFT 10 MM HEIGHT; PROSTHESIS, KNEE

Catalog Number	42512800710
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: medical product: tibia fixed cemented left size e stem extension use required: catalog#42542007101, lot#66640096.Customer has indicated that the product will not be returned to zimmer biomet for investigation per hospital policy.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during an initial left total knee arthroplasty, the total articular surface would not engage with the tibial tray.There was no surgical delay or patient impact as a result of the malfunction and a second device was used to complete the procedure without additional complication.All available information has been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The event cannot be confirmed.Visual inspection of the provided images performed.Item number and lot number engraved onto device confirmed as correct.Unable to confirm from images if dovetail is compressed.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 were not provided.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 REVISION ARTICULAR SURFACE FIXED BEARING CCK LEFT 10 MM HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• 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: 20570895
• Report Number: 0001822565-2024-03434
• Device Sequence Number: 18199435
• Product Code: JWH
• UDI-Device Identifier: 00889024554313
• UDI-Public: (01)00889024554313(17)270727(10)65569700
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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: 42512800710
• Device Lot Number: 65569700
• 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: 10/08/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2022
• 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.
• Patient Sex: Prefer Not To Disclose