MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA THE PERSONALIZED KNEE SOLUTION; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	42542007902
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item#: 42560113513; lot#: 66808691.Item#: 42522100913; lot#: 65904112.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was requested but not returned by the hospital.The investigation is in process.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 the patient underwent a knee revision approximately four (4) months post-implantation due to loosening of the tibial component.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6 visual examination of the provided pictures identified an explanted tibial component with evidence of biological material and blood on the surface.No fractures or significant deformations are apparent on the implant itself from the view provided.The fixation features, including pegs or fins, seem intact without any visible cracks or damage.X-rays were provided and reviewed by mmi.They state that the pre-revision images demonstrated radiolucency along the tibial implant, indicating it was loose, although alignment was maintained.The bone quality appeared mildly osteopenic.Post-operative images showed anatomic alignment of the right knee arthroplasty.The reviewing radiologist confirmed the loosening of the right tibial implant, noting that the loosening was at the bone-metal interfaces with minimal cement present.There were no indications of malalignment or patient anatomical issues contributing to the loosening.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.Complaint is confirmed based on x-rays provided.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: PERSONA THE PERSONALIZED KNEE SOLUTION
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED
• 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: 20466206
• Report Number: 0001822565-2024-03295
• Device Sequence Number: 20640064
• Product Code: JWH
• UDI-Device Identifier: 00889024562905
• UDI-Public: (01)00889024562905(17)321107(10)65569912
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2024

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 Catalogue Number: 42542007902
• Device Lot Number: 65569912
• 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: 09/25/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2022
• 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
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male