MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REVISION CEMENTED FEMORAL POSTERIOR AUGMENT SIZE 7, 7+ 5 MM THICKNESS; 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); Pain (1994)
Date of Event	03/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced two (2) falls approximately seventeen (17) months and forty (40) months following a right knee arthroplasty.The patient was prescribed anti-inflammatories and rehabilitation was recommended.No additional patient consequences were reported.Initial operative notes noted no intraoperative complications.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona revision cemented femoral component plus right size 7+, catalog #: 42504606212, lot #: 64667172.Persona revision straight splined uncemented stem extension 14 mm x +135mm, catalog #: 42560113514, lot #: 64769881.Persona revision cemented femoral posterior augment size 7, 7+ 5 mm thickness, catalog #: 42556806205, lot #: 64707490.Persona revision cemented tibial component right size e, catalog #: 42542007102, lot #: 64454893.Persona revision straight splined uncemented stem extension 13 mm x +135 mm, catalog #: 42560113513, lot #: 64729149.Persona revision constrained condylar knee articular surface right 14 mm, catalog #: 42522800714, lot #: 64349197.E1 - surgeon name - dr.(b)(6).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
Upon receipt of additional information, it was determined that the reported event did not result in serious injury and did not require medical intervention.Zimmer biomet does not consider this to be a reportable event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PERSONA REVISION CEMENTED FEMORAL POSTERIOR AUGMENT SIZE 7, 7+ 5 MM THICKNESS
• 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: 19721704
• Report Number: 0001822565-2024-02330
• Device Sequence Number: 8275207
• Product Code: JWH
• UDI-Device Identifier: 00889024556928
• UDI-Public: (01)00889024556928(17)291130(10)64610707
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2024

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: 42556806205
• Device Lot Number: 64610707
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2019
• 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: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native