MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VAN PS OPEN INTL FEM-RT 65; 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); Fibrosis (3167)
Date of Event	02/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 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, series a standard 3 peg patella 184762 lot 047990, palacos r 1x40 bone cement catalog 00111214001 lot 83264474.Customer has not indicated that the product will 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.
Event or Problem 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: b4, b5, g4, h1, h2, h3, h6, h10.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 or Problem Description
No additional information reported.

• Brand Name: VAN PS OPEN INTL FEM-RT 65
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9087867
• Report Number: 0001825034-2019-04193
• Device Sequence Number: 19537951
• Product Code: JWH
• UDI-Device Identifier: 00880304270794
• UDI-Public: (01)00880304270794
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/24/2026
• Device Model Number: N/A
• Device Catalogue Number: 183108
• Device Lot Number: J3747375
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 01/06/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 83