MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA ARTICULAR SURFACE FIXED BEARING CCK LEFT 14 MM HEIGHT; PROSTHESIS, KNEE

Catalog Number	42512800414
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: femur cemented plus left size 3: catalog#42504605411, lot#64767854; tibia fixed cemented left size c: catalog#42542006401, lot#64835284; femoral distal augment cemented size 3, 3+ 5 mm thickness: catalog#42556605405, lot#64661792; femoral distal augment cemented size 3, 3+ 5 mm thickness: catalog#42556605405, lot#64953971; femoral posterior augment cemented size 3, 3+ 5 mm thickness: catalog#42556805405, lot#64508957; stem extension tapered cemented 14 mm diameter +75 mm length: catalog#42560007514, lot#64863109; stem extension 3mm offset splined uncemented 11 mm diameter +135 mm length: catalog#42560313511, lot#64799440.G2: foreign: japan.The product will not be returned to zimmer biomet for investigation, as the product currently remains implanted.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 a patient underwent an initial total knee procedure.Subsequently, three years post-implantation, the set screw of the articular surface backed out of the bearing.A revision surgery is pending to replace the affected screw.Lt was reported that no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h4; h6; h11.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.The condition of the components is unknown.Device history record was reviewed and no discrepancies related to the reported event were found.X-ray review by third party healthcare professional states that the tibial screw appears to have backed out into the intercondylar region.Root cause was unable to be determined.Reported event was confirmed by review of provided radiographs.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 at time of this report.

• Brand Name: PERSONA ARTICULAR SURFACE FIXED BEARING CCK LEFT 14 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: 19567175
• Report Number: 0001822565-2024-02062
• Device Sequence Number: 6112739
• Product Code: JWH
• UDI-Device Identifier: 00889024554061
• UDI-Public: (01)00889024554061(17)250131(10)64638903
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 11/12/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Catalogue Number: 42512800414
• Device Lot Number: 64638903
• 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: 05/21/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2020
• 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