MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING (CCK) RIGHT 10 MM HEIGHT; PROSTHESIS, KNEE

Catalog Number	42522800710
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); Arthrofibrosis (4885)
Date of Event	04/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).H3- customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient¿s articular surface was revised due to unknown reasons.Attempts to obtain additional information have been made; however, no more information is available at this time.
Event or Problem Description
It was reported that a patient was revised approximately one and half years post implantation due to arthrofibrosis.No intraoperative complications were noted.Attempts to obtain additional information have been made; however, no more information is available.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.\ \ updated: b4, b5, d2b, g1, g3, g6, h1, h2, h3, h6, and h11.\ \ corrected: h6 (component code).\ \ no product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.\ \ review of the reported event by a health care professional found: \ \ 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.\ \ this is a limited investigation, as per (b)(4), a review of the device history record and complaint history review will not be completed for limited investigation complaints as the product meets the applicable acceptance criteria.\ \ the root cause of the reported event was determined to be unrelated to the device.\ \ this complaint is not confirmed.\ \ 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.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.\ \ updated: b4, b5, b7, d2b, g1, g3, g6, h1, h2, h6, and h11\ \ corrected: e1, e2.

• Brand Name: ARTICULAR SURFACE FIXED BEARING (CCK) RIGHT 10 MM HEIGHT
• 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: 24291821
• Report Number: 0001822565-2026-00437
• Device Sequence Number: 18488820
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2026

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 Expiration Date: 12/31/2024
• Device Catalogue Number: 42522800710
• Device Lot Number: 64615592
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 06/04/2026; 06/26/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 07/01/2026; 07/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 250 LB