MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING CONSTRAINED; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Adhesion(s) (1695); Loss of Range of Motion (2032); Scar Tissue (2060)

Event Date 11/18/2019

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Concomitant medical products: femur cemented posterior stabilized; p/n: 42500006002, l/n: 64031818, articular surface fixed bearing; p/n: 42522600512, l/n: 64042175, stem extension tapered cemented; p/n: 42557000114, l/n: 64412334, tibia cemented 5 degree stemmed; p/n: 42532006702, l/n: 64367667, all poly patella cemented; p/n: 42540000032, l/n: 64394938.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 event, please see associated reports: 3007963827 - 2019 - 00350, 3007963827 - 2019 - 00351.Remains implanted.

Event Description

It was reported the patient underwent a manipulation under anesthesia procedure 2 month post-implantation due to arthrofibrosis.Subsequently, no revision occurred.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.Updated: a5, b4, b5, d4, g4, g7.Additional: h1, h2, h3, h6, h10.D4 udi: (b)(4).Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following; patient visited 6 weeks post tka surgery, her - health state was 50, eq5d.76, kss objective 86, rom 90 degrees, no mild pain, walking with cane.The patient underwent manipulation due to anesthesia due to arthrofibrosis with postoperative rom 0-135degrees, complication resolved.During mua noted easily broke up adhesion/scar tissue and able to flex knee 135 degrees and hence issue was resolved.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.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

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

• Brand Name: ARTICULAR SURFACE FIXED BEARING CONSTRAINED
• 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: 9467258
• MDR Text Key: 170712376
• Report Number: 3007963827-2019-00351
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K123459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 42522600512
• Device Lot Number: 64042175
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2020
• 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: 67 YR
• Patient Weight: 68