MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL POLY PATELLA CEMENTED 32 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); Loss of Range of Motion (2032); Scar Tissue (2060)
Date of Event	01/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial right total knee arthroplasty.Approximately 2 months post implantation, the patient underwent manipulation under anesthesia due to decreased range of motion, adhesions, and scar tissue.The issue was resolved.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 42502006002 - femoral component - 64474776.42532007101 - articular surface - 64461587.42532007102 - tibial component - 64988395.Unknown cement.It was reported a patient underwent manipulation under anesthesia due to arthrofibrosis approximately 2 months postop.According to tabers medical dictionary ¿ manipulation of a joint is a mobilization technique, sometimes involving a rapid thrust or stretching of a joint, with or without anesthesia.With anesthesia is (mua).Per clinical orthropaedics and related research, mua is used to treat and resolve arthrofibrosis (scar tissue) which can develop after any surgical intervention.This procedure is performed to increase articular motion and reduce chronic pain from arthrofibrosis.The indication for manipulation under anesthesia is related to limited range of motion and stiffness due to adhesions/scar tissue.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2022-00093, 3007963827-2022-00094.

• Brand Name: ALL POLY PATELLA CEMENTED 32 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14086750
• Report Number: 0002648920-2022-00087
• Device Sequence Number: 5276075
• Product Code: MBH
• UDI-Device Identifier: 00889024643703
• UDI-Public: (01)00889024643703(17)290915(10)65134409
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 04/11/2022

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: 42540000032
• Device Lot Number: 65134409
• 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: 03/24/2022
• Initial Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2021
• 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: 71 KG
• Patient Race: White