MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 12 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Loss of Range of Motion (2032); Scar Tissue (2060); Limited Mobility Of The Implanted Joint (2671)

Event Date 07/09/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2020-00185, and 0002648920-2020-00362.Concomitant medical devices: femur cemented cruciate retaining (cr) standard left size 8 catalog#: 42502606401 lot#: 64439138, all poly patella cemented 38 mm diameter catalog#: 42540000038 lot#: 64580484, natural tibia cemented 5 degree stemmed left size e catalog#: 42532007101 lot#: 64459817.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 Description

It was reported that patient underwent left knee manipulation under anesthesia approximately two months after initial implantation due to stiffness, difficulty ambulating, limited range of motion, and a diagnosis of arthrofibrosis.Attempts have been made and no further information has been provided.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Arthrofibrosis is defined as a complication of injury or trauma where an excessive scar tissue response leads to painful restriction of joint motion, with scar tissue forming within the joint and surrounding soft tissue spaces and persisting despite rehabilitation exercises and stretches.A manipulation of the joint is needed to loosen the scar tissue to regain range of motion.Manipulation under anesthesia is a non-invasive technique performed for treating stiffness and poor range of motion following total joint replacement.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.As the indication for manipulation under anesthesia is related to arthrofibrosis, limited range of motion and stiffness, complaint categories will be coded as medical : adhesions/scar tissue, medical: range of motion (rom): limited mobility and medical: stiffness.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 12 MM HEIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 10356047
• MDR Text Key: 201361859
• Report Number: 3007963827-2020-00186
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K150090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 42512100812
• Device Lot Number: 64419807
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 08/03/2020
• Supplement Dates Manufacturer Received: 08/07/2020; 09/25/2020
• Supplement Dates FDA Received: 08/31/2020; 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 79