MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CR ILOK FEM-RT 65; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Pain (1994); Osteopenia/ Osteoporosis (2651); Joint effusion (4849)
Date of Event	07/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2024-00270, 0001825034-2024-00272, and 0001825034-2024-00273.D10-medical product: tibial bearing (as) 71 mm width 14 mm thickness, item# ve189064, lot# 64469192.Series a pat std 25 3 peg, item# 184760, lot# 807800.Biomet cc cruciate tray 71mm, item# 141233, lot# j6869986.Bone screw self-tapping 6.5 mm dia.25 mm length, item# 00625006525, lot# 64611734 qty (b)(4).Biomet bc r 1x40 us, item# 110035368, lot# f2701z12ba, qty (b)(4).H3- customer has indicated that the product will not 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 a patient was revised approximately two years and four months post implantation due to pain, instability, effusions, and patella impingement with malalignment.Attempts to obtain additional information have been made; however, no more information is available.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.The radiographs were not submitted as sufficient information was provided via the written medical records.Additional review of the radiographs would not enhance the investigation.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: small joint effusion negative for synovitis; moderate swelling; subluxation of patella with maltracking and impingement; no fracture or loosening identified; persistent pain and instability; femoral bone loss identified.It is mentioned in the revision notes that the patella was undersized; however, the size of the patella would have been chosen based on following surgical technique during the initial surgery and confirmed during trialing to check range of motion and stability of the knee.Therefore, no issues are found with the patella sizing.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.This complaint has been confirmed by review of the provided medical records.If any further information is received which would change or alter any conclusions or information, a supplemental medwatch will be filed accordingly.Zimmer biomet will continue to monitor for trends.H6: component code: proposed component (annex g) code is: - mechanical (g04) - femur.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: VANGUARD CR ILOK FEM-RT 65
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18623309
• Report Number: 0001825034-2024-00271
• Device Sequence Number: 20694138
• Product Code: JWH
• UDI-Device Identifier: 00880304270404
• UDI-Public: (01)00880304270404(17)301130(10)J6917396
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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: 183008
• Device Lot Number: J6917396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 131 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American