MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA FEMUR CEMENTED STANDARD RIGHT SIZE 11; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Loss of Range of Motion (2032); Scar Tissue (2060); Swelling/ Edema (4577)
Date of Event	01/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient had an initial right total knee arthroplasty followed by a manipulation under anesthesia and revision one year eleven months post implantation due to aseptic failure.Subsequently, the patient underwent a second manipulation under anesthesia two months later due to swelling, limited range of motion, stiffness, adhesions, and scar tissue.All implants remain in place.
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) ------------------------------------------- 42522601010 persona articular surface fixed bearing (cps) rt 10mm lot# 63738909 additional associated products(not reported) ------------------------------------------- 42540000041 all poly patella cemented 41 mm di lot# 64825538 42556807005 femoral posterior augment cemented size 11, 11+ 5mm lot# 64485582 42545001011 femoral central cone size small lot# 64627878 42556607005 femoral distal augment cemented size 11, 11+ 5mm lot# 64363695 42556607005 femoral distal augment cemented size 11, 11+ 5mm lot# 64661433 42556807005 femoral posterior augment cemented size 11, 11+ 5mm lot# 64661624 42560113520 stem ext straight splined uncemented 20mm dia +135mm l lot# 64567557 42545000513 tibial central cone size large lot# 64643019 42542007902 tibia fixed cemented right size g lot# 64507531 42560317514 stem ext 3mm offset splined uncemented 14mm dia +175mm l lot# 64642454 5036963 palacos cement lot# 94934912 5036963 palacos cement lot# 94434814 5036963 palacos cement lot# 93904859.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g3, g6, h1, h2, h3, h6, h10, h11.Arthrofibrosis is defined as the development of fibrous scar tissue within or surrounding a joint.Arthrofibrosis is a known postoperative procedure related complication that can occur from surgical implantation of new joint replacement as well as from previous injuries or surgical procedures.Scar tissue formation is a normal healing response; however, the buildup of such can result in pain, stiffness, limited range of motion, and difficulty properly ambulating.If excess scar tissue develops, conservative measures such as exercises or physical therapy would be attempted first.If these attempts fail, surgical intervention such as manipulation under anesthesia, arthroscopic arthrolysis, or open arthrotomy would become necessary to remove the fibrous tissue and restore joint function.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 FEMUR CEMENTED STANDARD RIGHT SIZE 11
• 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: 19139759
• Report Number: 0001822565-2024-01325
• Device Sequence Number: 18254188
• Product Code: JWH
• UDI-Device Identifier: 00889024562608
• UDI-Public: (01)00889024562608(17)300825(10)64857989
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 08/01/2024

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: 42504607002
• Device Lot Number: 64857989
• 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: 03/28/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2020
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White