MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA FEMORAL POSTERIOR AUGMENT CEMENTED SIZE 9, 9+ 10 MM; 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); Insufficient Information (4580)
Date of Event	07/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient began to have knee pain after an unknown injury, approximately three years post implantation.Patient was prescribed anti-inflammatories, ice, and home exercises program for quad strengthening.All implants remain in place and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Customer 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 associated products(reported).42504606611 persona femur cemented plus left size 9+ lot# 64683471.42556806615 persona femoral posterior augment cemented size 9, 9+ 15mm lot# 64617984.42556606605 persona femoral distal augment cemented size 9, 9+ 5mm lot# 64664216.42560613515 persona stem ext 6mm offset splined uncemented 15mm dia 135mm l lot# 64695870.42542007501 persona tibia fixed cemented left size f lot# 64495996.42512800724 persona articular surface fixed bearing (cck) left 24mm lot# 64559524.42560613515 persona stem ext 6mm offset splined uncemented 15mm dia 135mm l lot# 64695870.
Additional Manufacturer Narrative
Upon receiving additional information, it was determined that the part referenced should not have been reported as it was not believed to have contributed to or caused the event.The initial report should be voided.
Event or Problem Description
No additional information to report.

• Brand Name: PERSONA FEMORAL POSTERIOR AUGMENT CEMENTED SIZE 9, 9+ 10 MM
• 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: 19566864
• Report Number: 0001822565-2024-02045
• Device Sequence Number: 20573874
• Product Code: JWH
• UDI-Device Identifier: 00889024557000
• UDI-Public: (01)00889024557000(17)291231(10)64624151
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K181947
• 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): 07/22/2024

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: 42556806610
• Device Lot Number: 64624151
• 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: 05/24/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2019
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White