MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SERIES A PAT STD 28 3 PEG; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Fibrosis (3167)

Event Date 02/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: vanguard femoral right catalog 183108 lot j3747375, vanguard tibial bearing 10x63/67mm catalog 183620 lot 103990, biomet cruciate tray 63mm catalog 141231 lot j3730031, vanguard femoral pegs set 2 catalog 183099 lot 217990, palacos r 1x40 bone cement catalog 00111214001 lot 83264474.Reported event was confirmed through review of medical records.Device history record was reviewed and no discrepancies were found.Root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that patient was experiencing pain and stiffness and subsequently underwent a manipulation under anesthesia approximately six months post right knee arthroplasty due to arthrofibrosis.

• Brand Name: SERIES A PAT STD 28 3 PEG
• 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: 9554482
• MDR Text Key: 173910800
• Report Number: 0001822565-2020-00050
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00880304431638
• UDI-Public: (01)00880304431638
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2021
• Device Model Number: N/A
• Device Catalogue Number: 184762
• Device Lot Number: 047990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2016
• 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 Weight: 83