MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE USE WITH PLATE 5,6 SIZE 12 MM HEIGHT; 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); Scar Tissue (2060); Ambulation or Postural Difficulties (2544)
Date of Event	12/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.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 a patient underwent an initial right total knee arthroplasty.Subsequently, the patient underwent a manipulation under anesthesia due to arthrofibrosis 2 months post procedure.The patient was ultimately revised 7 months post procedure due to ongoing pain and difficulties.The articular surface was explanted and exchanged.
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.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.Review of medical records provided noted that the patient continued to experience scar tissue and range of motion complications immediately after manipulation until the open lysis of adhesions and poly revision due to severe scar tissue occurred.During the surgery, extensive extremely dense scar tissue was encountered and removed.The patient was also noted to have "kinesiophobia" - a fear of moving the joint, as a contributing factor.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ARTICULAR SURFACE USE WITH PLATE 5,6 SIZE 12 MM HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11984162
• Report Number: 0001822565-2021-01633
• Device Sequence Number: 1058410
• Product Code: JWH
• UDI-Device Identifier: 00889024208025
• UDI-Public: (01)00889024208025(17)241130(10)64434199
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

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: 11/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 00595204012
• Device Lot Number: 64434199
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 06/11/2021
• Supplement Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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: Hospitalization; Required Intervention
• Patient Weight: 80