MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CR ILOK FEM-RT 70; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Swelling (2091)
Date of Event	06/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 184768 - patella - 266560, ep-189100 - bearing - 712340, 141205 - tibial locking bar - 244200, 141235 - tibial tray - j6428643, 110034355 - refobacin bc r 1x40 us - 745eah2108, 110034355 - refobacin bc r 1x40 us - 731bae2909.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.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: 0001825034-2020-00663.0001825034-2020-00665.
Event or Problem Description
It was reported that the patient underwent manipulation under anesthesia approximately three months post implantation to help with range of motion.The patient also noted that he felt knee popping which was accompanied by pain and swelling.
Additional Manufacturer Narrative
No devices or photos were received; therefore the condition of the components is unknown.The dhr was reviewed and no discrepancies relevant to the reported event were found.Office visit notes states that the patient reported catching, popping, swelling, and pain post initial surgery.The patient was seen with rom 0-91 degrees, knee stable, incision well-healed, and xray review demonstrates retained interference screws from acl reconstruction.Manipulation under anesthesia was performed with rom 0-120 degrees.A 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 further event information available at the time of this report.

• Brand Name: VANGUARD CR ILOK FEM-RT 70
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9701800
• Report Number: 0001825034-2020-00664
• Device Sequence Number: 13922546
• Product Code: JWH
• UDI-Device Identifier: 00880304270435
• UDI-Public: 00880304270435
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K113550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2020

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: 06/04/2026
• Device Model Number: N/A
• Device Catalogue Number: 183012
• Device Lot Number: J3811647
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 03/02/2020
• 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: Other
• Patient Weight: 112