MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA ARTICULAR SURFACE FIXED BEARING (CPS) RT 10MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Loss of Range of Motion (2032); Scar Tissue (2060); Swelling/ Edema (4577)

Event Date 01/27/2021

Event Type  Injury  

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) 42504607002 persona femur cemented standard right size 11 lot# 64857989.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.

Event 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.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.

• Brand Name: PERSONA ARTICULAR SURFACE FIXED BEARING (CPS) RT 10MM
• Type of Device: 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: 19139756
• MDR Text Key: 340560737
• Report Number: 0001822565-2024-01324
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024244788
• UDI-Public: (01)00889024244788(17)220731(10)63738909
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 42522601010
• Device Lot Number: 63738909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 07/31/2024
• Supplement Dates FDA Received: 08/01/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H11 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White