MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REVISION CEMENTED FEMUR PLUS RIGHT SIZE 9+; 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); Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	02/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient is being considered for a right knee arthroplasty revision to increase stability due to flexion laxity and constant pain approximately three (3) years post-operatively.The patient has been prescribed ultram for pain management.No additional patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products - persona posterior stabilized articular surface right 12mm catalog #: 42522600712 lot #: 64420428, persona offset stem extension 3mm catalog #: 42560317518 lot #: 64530290, persona cemented tibia right size # catalog #: 42542007102 lot #: 64454891, persona offset splined uncemented stem extension 20mm catalog #: 42560613520 lot #: 64559276, palacos r 1x40 bone cement catalog #: 00111214001 lot #: 5036963.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: 3007963827-2023-00055.
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 information.H6 - component code - proposed code is mechanical (04) - femur.Medical records provided confirmed the event reported.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 CEMENTED FEMUR PLUS RIGHT SIZE 9+
• 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: 16609446
• Report Number: 0001822565-2023-00773
• Device Sequence Number: 4817476
• Product Code: JWH
• UDI-Device Identifier: 00889024562721
• UDI-Public: (01)00889024562721(17)291231(10)64600374
• 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): 04/28/2023

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: 42504606612
• Device Lot Number: 64600374
• 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: 02/27/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2020
• 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: Other
• Patient Sex: Female
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American