MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GENDER SOLUTIONS PRECOAT PATELLO-FEMORAL TROCHLEA COMPONENT RIGHT SIZE 3; 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); Scar Tissue (2060); Synovitis (2094); Unspecified Tissue Injury (4559)
Date of Event	10/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant devices: persona cemented all poly patella 35mm catalog #: 42540000035 lot #: 64825568 the complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0002648920-2022-00061.Investigation incomplete.
Event or Problem Description
It was reported that the patient underwent a manipulation under anesthesia to address arthrofibrosis approximately one (1) year post-operatively.Operative notes from the manipulation noted arthrofibrosis, intraarticular scar with impingement and chronic synovitis.An arthroscopy with a synovectomy was performed and the patient's range of motion increased from 0-110° to 0-130° during the manipulation.No intraoperative complications were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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.Per clinical orthopaedics and related research, manipulation is used to treat and resolve arthrofibrosis, or scar tissue.This procedure is performed to increase articular motion and reduce chronic pain from arthrofibrosis.As the indication for manipulation is related to limited range of motion and stiffness due to adhesions/scar tissue, the root cause is attributed to non-device related factors.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: GENDER SOLUTIONS PRECOAT PATELLO-FEMORAL TROCHLEA COMPONENT RIGHT SIZE 3
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13896172
• Report Number: 0001822565-2022-00808
• Device Sequence Number: 4303065
• Product Code: JWH
• UDI-Device Identifier: 00889024205864
• UDI-Public: (01)00889024205864(17)300824(10)64716002
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• 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
• Report Date (Section B): 06/24/2022

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: 00592601302
• Device Lot Number: 64716002
• 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: 03/03/2022
• Supplement Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White