MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REVISION CEMENTED STANDARD FEMORAL COMPONENT LEFT SIZE 5; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Joint Laxity (4526); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	02/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona posterior stabilized articular surface left 16mm, catalog #: 42512400416, lot #: 63756949.Persona revision offset splined uncemented stem extension 3mm x 13mm x +135mm, catalog #: 42560313513, lot #: 64642627.Persona revision cemented tibial tray left size c, catalog #: 42542006401, lot #: 64334622.Persona revision offset splined uncemented stem extension 6mm x 12mm x +135mm, catalog #: 42560613512, lot #: 64783533, persona revision central tibial cone, catalog #: 42545000508, lot #: 64643004.Persona revision cemented tibial augment half block left lateral size cd 10mm, catalog #: 42555803110, lot #: 64664285.Persona revision cemented tibial augment half block left lateral size cd 10mm, catalog #: 42555803110, lot #: 64661873.Unknown palacos bone cement.H6 - component code - proposed code is mechanical (04) - femur.Medical records provided were reviewed by a health care professional 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.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001822565-2024-00975.
Event or Problem Description
It was reported that the patient underwent a left knee arthroplasty revision of the articular surface to address pain, instability, swelling and effusions approximately three (3) years following the patient's last knee procedure.During the revision, significant scar tissue was identified.The articular surface was exchanged for a larger size and the surgery was completed without complication.Initial operative notes noted no intraoperative complications.Revision operative notes noted that the patient was being revised for increasing global instability over the previous six (6) to nine (9) months.Upon examination, the patient had about five (5) degrees of recurvatum and significant instability at terminal extension with about one (1) centimeter of coronal plane instability.During the procedure, significant scar and fibrotic tissue was debrided.All implants were examined and appeared stable and the articular surface was replaced with a larger size with no intraoperative complications noted.

• Brand Name: PERSONA REVISION CEMENTED STANDARD FEMORAL COMPONENT LEFT SIZE 5
• 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: 18948833
• Report Number: 0001822565-2024-00976
• Device Sequence Number: 20846093
• Product Code: JWH
• UDI-Device Identifier: 00889024562530
• UDI-Public: (01)00889024562530(17)300719(10)64815371
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/21/2024

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: 42504605801
• Device Lot Number: 64815371
• 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: 07/23/2023
• Initial Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White