MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE G; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Swelling/ Edema (4577)
Date of Event	02/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an arthroscopic debridement of scar tissue due to pain and swelling approximately six months post implantation.Upon follow-up, the patient showed improvement in pain.Attempts to obtain additional information have been made; however, no more information is available.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 3007963827-2022-00030, 3007963827-2022-00032, 0002648920-2022-00020.Concomitant medical products: femur cemented (ps) standard right size 11, item#: 42500607002, lot#: 64568095.Articular surface fixed bearing (ps) right 13 mm height, item#: 42522401013, lot#: 64162167.All-poly patella cemented 35 mm diameter, item#: 42540200035, lot#: 64622008.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Arthrofibrosis is defined as the development of fibrous tissue or scar tissue in a joint.Arthrofibrosis is a known postoperative procedure related complication that can occur from not only surgical implantation of new joint, but also previous injuries to the joint, or surgical procedures.As joint trauma, injury or surgical procedures increase the risk for development of these fibrosis or scar tissue formation, thus causing contracture of the tissue.This results in the patient having increased symptoms of pain, limp, weakness, swelling, and inability to have full range of motion.Symptoms can depend on the location of the arthrofibrosis tissue.If this develops, conservative measures would be attempted first, such as mua or therapy.If conservative measures fail, surgical intervention will become necessary to remove the fibrous tissue causing the problems.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: TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE G
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13366056
• Report Number: 3007963827-2022-00031
• Device Sequence Number: 14797432
• Product Code: MBH
• UDI-Device Identifier: 00889024471108
• UDI-Public: (01)00889024471108(17)191031(10)64446156
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2022

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: 42532007902
• Device Lot Number: 64446156
• 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: 01/06/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 114 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American