MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 VNGD AS TIB BRG 12X83; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060)
Date of Event	05/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01750 and 0001825034-2022-01751.Associated products: vanguard cr ilok fem-rt 70 catalog#: 183012 lot#: j6573228.Biomet cc i-beam tray 83mm catalog#: 141226 lot#: j6632322.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
It was reported via study that patient underwent a manipulation under anesthesia approximately two-and-a-half months post-implantation due to pain and limited range of motion.The patient has now completed the study with no further complications.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.It was reported a patient had a total knee arthroplasty.Subsequently, three months later, underwent a manipulation under anesthesia due to limited range of motion and stiffness.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 (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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported that patient underwent an initial right knee arthroplasty.The patient was doing well until sustaining a fall, approximately 5 weeks post-op, due to an unknown cause.Subsequently, after the fall, the patient¿s range of motion began to decline and experienced pain and stiffness, requiring a manipulation under anesthesia two-and-a-half months post implantation.The patient regained full range of motion and since has completed the study with no further complications.

• Brand Name: E1 VNGD AS TIB BRG 12X83
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15156596
• Report Number: 0001825034-2022-01751
• Device Sequence Number: 17459920
• Product Code: JWH
• UDI-Device Identifier: 00880304465800
• UDI-Public: (01)00880304465800(17)240928(10)861720
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• 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,Followup,Followup
• Report Date (Section B): 09/16/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2024
• Device Model Number: N/A
• Device Catalogue Number: EP-189122
• Device Lot Number: 861720
• 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: 07/10/2022
• Supplement Date Received by Manufacturer: 08/18/2022; 09/15/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 09/13/2022; 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 142 KG
• Patient Race: White