MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL POLY PATELLA CEMENTED 29 MM DIAMETER; 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); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient has an initial left total knee arthroplasty.Subsequently, patient had a manipulation under anesthesia on an unknown date due to arthrofibrosis, stiffness, pain, and decreased rom.Thick abundant scar tissue was excised throughout the joint.Unfortunately symptoms continued with addition of swelling.Knee aspiration x 2 with no growth reported and negative for infection.
Additional Manufacturer Narrative
(b)(4).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.Postoperative joint swelling is a localized swelling or inflammation which is described as an accumulation of fluid in the interstitium, the space between cells, located beneath the skin and in cavities of the body.Inflammation from surgical trauma causes the release of moderators called cytokines.Swelling may increase during activities or when sitting or standing in one position for an extended period.Swelling or inflammation is the body¿s natural response to heal damaged tissue postoperatively.Additional associated products & mdrs 42502605801 femur cemented cruciate retaining (cr) std lt iz 5 lot# 63784658.Mdr: 3007963827-2023-00044.42532006701 tibia cemented 5 degree stemmed lt sz d lot# 63987513.Mdr: 3007963827-2023-00045.42511200413 articular surface fixed bearing ultracongruent lt 13mm lot# 62638083.Mdr: 0002648920-2023-00042.42557000114 stem extension tapered cemented 14mm dia +30 mm lot# unk mdr: 0001822565-2023-00636.Additional associated products unk competitor bone cement.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: ALL POLY PATELLA CEMENTED 29 MM DIAMETER
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16521049
• Report Number: 0002648920-2023-00043
• Device Sequence Number: 20447717
• Product Code: JWH
• UDI-Device Identifier: 00889024643697
• UDI-Public: (01)00889024643697(17)260531(10)64063564
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2023

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 Expiration Date: 05/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 42540000029
• Device Lot Number: 64063564
• 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: 02/16/2023
• Initial Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2018
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 102 KG