MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGARD XP FEMORAL COMPONENT WITH PEGS LEFT 57.5MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - vanguard xp-as e1 left medial/right lateral tibial bearing 14mm x 65/67mm catalog #: 195547 lot #: 266990, vanguard xp-as e1 right medial/left lateral tibial bearing 14mm x 65/67mm catalog #: 195610 lot #: 680750, vanguard xp cruciate retaining tibial tray 65mm catalog #: 195270 lot #: 342320, series a thin 3 peg patella catalog #: 184784 lot #: 062110.G2 - report source - foreign: event occurred in japan.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded.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: 0001825034-2024-00028, 0001825034-2024-00029.H3 other text : investigation incomplete.
Event or Problem Description
It was reported that the patient underwent a left knee arthroplasty revision to address pain and dislocation of the femoral component and tibial bearings approximately two (2) months post-operatively.Attempts have been made; however, no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: proposed component code: mechanical (g04) femur.The reported event was confirmed via provided radiographs; no product or pictures were performed; visual and dimensional evaluations could not be performed.Radiographs reviewed by a healthcare professional identified lateral dislocation of the tibial component, possible poly wear, and possible metal-on-metal with the femoral component.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause could not 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.
Event or Problem Description
No additional information to report.

• Brand Name: VANGARD XP FEMORAL COMPONENT WITH PEGS LEFT 57.5MM
• 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: 18464343
• Report Number: 0001825034-2024-00030
• Device Sequence Number: 7145661
• Product Code: MBH
• UDI-Device Identifier: 00880304560437
• UDI-Public: (01)00880304560437(17)300131(10)272320
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 05/23/2024

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: 195919
• Device Lot Number: 272320
• 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: 12/12/2023
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2020
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 63 KG