MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REVISION FEMORAL CENTRAL CONE SIZE SMALL; 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); Swelling/ Edema (4577)
Date of Event	01/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a ground level fall that resulted in a t11 compression fracture approximately eight (8) months following a left knee arthroplasty.The patient was hospitalized, given a thoracic-lumbar-sacral orthosis (tlso) brace and discharged to a skilled nursing facility.No additional patient consequences or interventions have been reported.Initial operative notes noted no intraoperative complications.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona revision femur cemented standard left size 7; catalog #: 42504606201; lot #: 64890498.Persona revision stem extension 3mm offset splined uncemented 14mm x +135mm; catalog #: 42560313514; lot #: 64783428.Persona revision femoral distal augment cemented size 7, 7+ 10mm; catalog #: 42556606210; lot #: 64336288.Persona revision femoral posterior augment cemented size 7, 7+ 5mm; catalog #: 42556806205; lot #: 64485573.Persona revision femoral posterior augment cemented size 7, 7+ 5mm; catalog #: 42556806205; lot #: 64610707.Persona revision femoral distal augment cemented size 7, 7+ 10mm; catalog #: 42556606210; lot #: 64613190.Persona revision tibia fixed cemented left size e; catalog #: 42542007101; lot #: 64938645.Persona revision stem extension 3mm offset splined uncemented 13mm x +135mm; catalog #: 42560313513; lot #: 64707668.Persona revision tibial augment cemented half block left medial size ef 10mm; catalog #: 42555805310; lot #: 64707264.Persona revision tibial central cone size medium catalog #: 42545000512; lot #: 64800271.Persona revision tibial augment cemented half block left lateral size ef 10mm; catalog #: 42555805110; lot #: 64680019.Persona posterior stabilized articular surface left 14mm; catalog #: 42512600714; lot #: 64686018.Unknown palacos cement; catalog #: ni; lot #: ni.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported that the patient has experienced ongoing pain, intermittent swelling, and several balance-related falls unrelated to the implanted devices that have resulted in spinal fracture and hospitalization since the patient's left knee arthroplasty.The surgeon does not recommend a revision at this time.Initial operative notes noted no intraoperative complications.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.Medical records received were reviewed, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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 REVISION FEMORAL CENTRAL CONE SIZE SMALL
• 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: 20238800
• Report Number: 0001822565-2024-02981
• Device Sequence Number: 8516787
• Product Code: JWH
• UDI-Device Identifier: 00889024560789
• UDI-Public: (01)00889024560789(17)300721(10)64751267
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2025

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: 42545001011
• Device Lot Number: 64751267
• 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: 08/27/2024
• Supplement Date Received by Manufacturer: 09/20/2024; 02/06/2025
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/10/2024; 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2020
• 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: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White