MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING(CR) NARROW RT SZ; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Scar Tissue (2060)
Date of Event	10/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient received an initial right total knee arthroplasty.Subsequently, underwent a manipulation, under anesthesia of the right knee two months post procedure, due to arthrofibrosis of the joint.No further complications were reported.Patient demonstrated overall improvement with pain, satisfaction, and quality of life and completed the study per protocol with no further interventions.
Additional Manufacturer Narrative
3013876692-2022- code: mechanical (g04) : femur.A manipulation under anesthesia was performed due to according to taber's 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 orthopedics and related research (how to treat the stiff total knee arthroplasty? a systematic review), mua is used to treat and resolve arthrofibrosis (scar tissue).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.Additional associated products & mdrs: 42532006402 tibia cemented 5 degree stemmed right size c lot# 64626511 mdr: 3007963827-2022-00142.42522200411 articular surface fixed bearing (uc) right 11 mm lot# 64418973 mdr: 3007963827-2022-00143.00587806529 nexgen complete knee solution, trabecular metal std primary patella lot# 64635672.Mdr: 3005751028-2022-00014.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: FEMUR CEMENTED CRUCIATE RETAINING(CR) NARROW RT SZ
• 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: 14496220
• Report Number: 3007963827-2022-00141
• Device Sequence Number: 17592208
• Product Code: JWH
• UDI-Device Identifier: 00889024229921
• UDI-Public: (01)00889024229921(17)300131(10)64633161
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/25/2022

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: 42502006202
• Device Lot Number: 64633161
• 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: 04/28/2022
• Initial Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2020
• 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
• 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: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American