MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CR ILOK FEM-RT 60; 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)
Date of Event	09/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00933, 0001825034-2020-00934, and 0001825034-2020-00935.Concomitant medical products: vngd ant stblzd brg 14x67 catalog#: 189044 lot#: 608430, series a pat std 31 3 peg catalog#: 184764 lot#: 639510, biomet cc i-beam tray 67mm catalog#: 141222 lot#: j6383447.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.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 a study patient underwent a right total knee arthroplasty.Subsequently, patient experienced pain and decreased rom.She received additional physical therapy, prescriptions, and three lumbar spine injections.The outcome was tolerated, but remains pending.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Reported event was confirmed by review of medical records.Office visit notes states that the patient had asa class iii, general anesthesia and adductor nerve block procedure and no adverse events occurred during or after surgery.Office notes (dated 03- december- 2019) state that patient had pain and rom: active 85 flexion/0 extension; passive 87 flexion/0 extension.Device history record 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.
Additional Manufacturer Narrative
Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.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 a study patient underwent a right total knee arthroplasty.Subsequently, patient experienced pain and decreased rom.She received additional physical therapy, prescriptions, three lumbar spine injections, and a manipulation under anesthesia.Patient was then revised due to stiffness.

• Brand Name: VANGUARD CR ILOK FEM-RT 60
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9769341
• Report Number: 0001825034-2020-00933
• Device Sequence Number: 2786764
• Product Code: JWH
• UDI-Device Identifier: 00880304270374
• UDI-Public: (01)00880304270374(17)290926(10)J6643232
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/19/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 183004
• Device Lot Number: J6643232
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 03/09/2020; 09/24/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 03/10/2020; 10/19/2020
• 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 Age: 45 YR
• Patient Weight: 118