MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD XP-XP E1 LEFT LATERAL BEARING 10MM X 63/65/67MM; 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	10/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - vanguard xp-as e1 left medial/right lateral tibial bearing 10mm x 65/67mm catalog #: 195543 lot #: 255250, vangard xp femoral component with pegs left 57.5mm catalog #: 195919 lot #: 272320, vanguard xp cruciate retaining tibial tray 65mm catalog #: 195270 lot #: 342320 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: 0001825034-2024-00022 0001825034-2024-00024 h3 other text : investigation incomplete.
Event or Problem Description
It was reported that the patient underwent a left knee arthroplasty revision to address patellar and tibial bearing dislocation and pain approximately one (1) year post-operatively.The patient's patella was resurfaced and the tibial bearings were replaced.Attempts have been made; however, no additional information is available.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.Reported event was unable to be confirmed.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.

• Brand Name: VANGUARD XP-XP E1 LEFT LATERAL BEARING 10MM X 63/65/67MM
• 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: 18464350
• Report Number: 0001825034-2024-00023
• Device Sequence Number: 20612206
• Product Code: MBH
• UDI-Device Identifier: 00880304552982
• UDI-Public: (01)00880304552982(17)260303(10)103500
• 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): 06/04/2024

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 Expiration Date: 03/03/2026
• Device Model Number: N/A
• Device Catalogue Number: 195808
• Device Lot Number: 103500
• 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: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 63 KG