MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CRUCIATE RETAINING FEMORAL COMPONENT RIGHT 75MM; 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); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	01/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - vanguard cruciate retaining femoral component right 75mm item #: 183014 lot #: j7168291, biomet tibial tray 75mm catalog #: 141234 lot #: j7267250 g2 - report source - foreign: event occurred in the netherlands.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device 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 patient; please see all reports associated with this event: 0001825034-2023-02727.H3 other text : investigation incomplete.
Event or Problem Description
It was reported that the patient experienced instability, pain and swelling approximately four (4) months following right knee arthroplasty.The surgeon advised a knee revision; however, the patient received a second opinion and has declined to proceed with a revision at this time.Initial operative notes noted no intraoperative complications.Attempts have been made; however, no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: h6: proposed component code: mechanical (g04) - femur.The reported event was confirmed by review of the provided medical records.No product or pictures were returned; thus, visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were reviewed by a healthcare professional and identified that findings conus with evidence of acl deficiency, instability, pain, and swelling reported.Radiographs were also provided and identified that the overall size was appropriate, and there were no signs of loosening, radiolucency, and wear.A definitive root cause could not be determined; however, findings concur with evidence of acl deficiency.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.
Event or Problem Description
No additional information to report.

• Brand Name: VANGUARD CRUCIATE RETAINING FEMORAL COMPONENT RIGHT 75MM
• 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: 18256102
• Report Number: 0001825034-2023-02726
• Device Sequence Number: 7108675
• Product Code: JWH
• UDI-Device Identifier: 00880304270459
• UDI-Public: (01)00880304270459(17)311217(10)J7168291
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K113550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 183014
• Device Lot Number: J7168291
• 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: 11/08/2023
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2021
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose