MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR TRABECULAR METAL CRUCIATE RETAINING (CR); 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)

Event Date 06/18/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical products: natural tibia trabecular metal two-peg porous fixed bearing catalog # 42530007102 lot # 64702610.Articular surface medial congruent (mc) catalog # 42522100810 lot # 64463596.Persona all poly patella catalog # 42540000035 lot # 64834784.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Multiple mdr reports were filled for this event: 0001822565-2021-01794, 3007963827-2021-00140, 0002648920-2021-00176.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).In the event a mua is unsuccessful in breaking up the adhesions/scar tissue a arthroscopic lysis of adhesions can occur.This is where the surgeon will go in and release the adhesions/scar tissue.These procedures are performed to increase articular motion and reduce chronic pain from arthrofibrosis.The indication for manipulation under anesthesia and/or arthroscopic lysis is related to limited range of motion and stiffness due to adhesions/scar tissue.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 Description

It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient underwent an arthroscopic lysis of adhesions with manipulation due to flexion contracture.Attempt for further information has been made, but no further information has been provided.

• Brand Name: FEMUR TRABECULAR METAL CRUCIATE RETAINING (CR)
• Type of Device: 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: 12099448
• MDR Text Key: 259369464
• Report Number: 0001822565-2021-01792
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42502806402
• Device Lot Number: 64834526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 167