MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA FEMUR TRABECULAR METAL CRUCIATE RETAINING; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Pain (1994)
Date of Event	03/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a knee revision approximately 16 days post implantation due to a periprosthetic fracture after a fall.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign - australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the patient underwent a right knee revision approximately 15 days post implantation due to pain and periprosthetic fracture from falling while walking to bathroom using a four-wheel walker and nursing assistance.All components exchanged with nexgen rotating hinge components without complications.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
No additional information to report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: proposed component code: mechanical (g04) - femur.The reported event was confirmed via provided medical records.Visual examination of provided photos identified explanted implants with foreign material covering the implants.Medical records were reviewed by a healthcare professional and identified the following: pre-revision, there was pain and x-ray confirmed supracondylar fracture above femur component.Revision op notes state that femur component and fracture fragment were excised and permanent components were placed with good rom and good stability.Radiographs were also provided and reviewed by a healthcare professional, which identified a comminuted and displaced periprosthetic fracture of the distal right femur, and severe osteopenia.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause could not be determined.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.

• Brand Name: PERSONA FEMUR TRABECULAR METAL CRUCIATE RETAINING
• 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: 19111139
• Report Number: 0001822565-2024-01240
• Device Sequence Number: 12851903
• Product Code: MBH
• UDI-Device Identifier: 00889024230767
• UDI-Public: (01)00889024230767(17)340202(10)66339306
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172524
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2024

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: 42502806202
• Device Lot Number: 66339306
• 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: 03/24/2024
• Supplement Date Received by Manufacturer: 04/15/2024; 06/28/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 05/06/2024; 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose