MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD XP PRIMARY TIBIAL TRAY 73MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices: unknown vanguard xp lateral tibial bearing catalog #: ni lot #: ni, unknown vanguard xp medial tibial bearing catalog #: ni lot #: ni, unknown vanguard femoral component catalog #: ni lot #: ni, g2 - report source - foreign: the event occurred in the united kingdom.The complainant 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 the patient underwent a manipulation under anesthesia two (2) months following right knee arthroplasty to address pain, stiffness, restricted range of motion and concern for arthrofibrosis.However, the patient continued to experience limited range of motion and was subsequently revised.During the revision, both the medial and lateral tibial bearings were noted to not be fully seated and the lateral tibial bearing was partially fractured.Arthrolysis and debridement were performed to remove scar tissue and the tibial bearings and locking bar were replaced.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h7, h6, h11.The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies were identified.The device was identified to be included within a recall due to the potential of a burr from manufacturing not allowing the locking bar to full assemble.However, as the device was not returned, this could not be confirmed.A definitive root cause could not be determined with the information provided.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 further event information available at the time of this report.

• Brand Name: VANGUARD XP PRIMARY TIBIAL TRAY 73MM
• 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: 20515545
• Report Number: 0001825034-2024-02482
• Device Sequence Number: 8532278
• Product Code: MBH
• UDI-Device Identifier: 00880304552272
• UDI-Public: (01)00880304552272(17)191009(10)780250
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K132873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

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 Expiration Date: 10/09/2019
• Device Model Number: N/A
• Device Catalogue Number: 195756
• Device Lot Number: 780250
• 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: 09/27/2024
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2014
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown