MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REVISION OFFSET SPLINED UNCEMENTED STEM EXTENSION 3MM X 12MM X +135MM; 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); Inflammation (1932); Pain (1994); Muscle/Tendon Damage (4532); Swelling/ Edema (4577)
Date of Event	02/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona revision cemented fixed tibial component right size e catalog #: 42542007102 lot #: 64817975, persona revision trabecular metal tibial central cone size x-small catalog #: 42545000510 lot #: 64800266, persona revision constrained condylar knee articular surface right 12mm catalog #: 42522800712 lot #: 64660505, persona revision cemented femoral component plus right size 9+ catalog #: 42504606612 lot #: 64867234, persona revision offset splined uncemented stem extension 3mm x 14mm x 135mm+ catalog #: 42560313514 lot #: 64799481, refobacin bone cement r 1x40 us catalog #: 110034355 lot #: 942bac2502, refobacin bone cement r 1x40 us catalog #: 110034355 lot #: 936bae2505.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.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001822565-2024-00885, 0001822565-2024-00887.H3 other text : investigation incomplete.
Event or Problem Description
It was reported that the patient was prescribed diclofenac, a foam roller and home exercises to address pain, instability, pes and iliotibial band tendonitis approximately two (2) years following right knee arthroplasty.Initial operative notes noted no intraoperative complications.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.H6 - component code - proposed code is mechanical (04) - stem.Medical records were provided and confirmed the reported event.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PERSONA REVISION OFFSET SPLINED UNCEMENTED STEM EXTENSION 3MM X 12MM X +135MM
• 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: 18895480
• Report Number: 0001822565-2024-00886
• Device Sequence Number: 7598375
• Product Code: JWH
• UDI-Device Identifier: 00887868250026
• UDI-Public: (01)00887868250026(17)300901(10)64853552
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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: 42560313512
• Device Lot Number: 64853552
• 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: 02/21/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2020
• 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
• 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 H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 94 KG