MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CR ILOK FEM-LT 62.5; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Loss of Range of Motion (2032); Scar Tissue (2060); Limited Mobility Of The Implanted Joint (2671)
Date of Event	10/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Udi : (b)(4).Associated products : item#:189040; vngd ant stblzd brg 10x67; lot#:510870; item#:141222; biomet cc i-beam tray 67mm; lot#:j6399511.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 01680.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) reviewed and no discrepancies related to the reported event were found.A definitive root cause cannot be determined.Mymobility records were provided and reviewed by a healthcare professional.Review found patient had rom 20-90 deg at 1 month.Mua performed on (b)(6) 2019 due to arthrofibrosis.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
The patient underwent a manipulation under anesthesia approximately 2 months post-op, due to arthrofibrosis stiffness.The issue was reported to have resolved one week after the mua without further complication.

• Brand Name: VANGUARD CR ILOK FEM-LT 62.5
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9962375
• Report Number: 0001825034-2020-01679
• Device Sequence Number: 19562464
• Product Code: JWH
• UDI-Device Identifier: 00880304270503
• UDI-Public: (01)00880304270503
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/14/2020

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 Model Number: N/A
• Device Catalogue Number: 183026
• Device Lot Number: J6553343
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 04/15/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 68