MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 10 MM HEIGHT USE WITH TIBIA; 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); Loss of Range of Motion (2032)
Date of Event	09/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent a right total knee arthroplasty.Approximately 4 months post implantation, the patient underwent manipulation under anesthesia due to pain, stiffness, and limited flexion.After the surgery, the patient continued to improve and has gained full range of motion.All implants remain in place.
Additional Manufacturer Narrative
(b)(4).It was reported a patient had a total knee arthroplasty.Subsequently, approximately four months later, underwent a manipulation under anesthesia due to pain, stiffness, and limited flexion.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 orthopaedics 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02885.

• Brand Name: ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 10 MM HEIGHT USE WITH TIBIA
• 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15543645
• Report Number: 3007963827-2022-00253
• Device Sequence Number: 6511253
• Product Code: MBH
• UDI-Device Identifier: 00889024468498
• UDI-Public: (01)00889024468498(17)241130(10)64463604
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K150090
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2022

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 Expiration Date: 11/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 42522100910
• Device Lot Number: 64463604
• 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: 09/14/2022
• Initial Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 127 KG