MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CRUCIATE RETAINING FEMORAL COMPONENT RIGHT 70MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Degraded (1153)

Patient Problem Failure of Implant (1924)

Event Date 09/14/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a right knee arthroplasty revision to address posterior knee subluxation of the tibial bearing approximately ten (10) years post-operatively.During the revision, the posterior medial tibial tray and distal medial femoral condyle appeared to be damaged from the subluxation.The surgeon preferred to avoid a total revision and only replaced the tibial bearing.Attempts have been made; however, no additional information is available.

Manufacturer Narrative

(b)(4).D10 - concomitant devices - vanguard cruciate retaining tibial bearing 10mm x 71/75mm catalog #: 183440, lot #: ni, polished finned tibial tray 75mm, catalog #: 141254 lot #: ni.G2 - report source - foreign: event occurred in australia.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: 0001825034-2023-02317.H3 other text: investigation incomplete.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and corrected information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-02317-1.H6: component codes: mechanical g4-femur visual examination of the provided pictures identified sign of use, and both bearing and femoral condyle noted to be worn.Lot identification is necessary for review of device history records, lot identification was not provided.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right knee arthroplasty malalignment as noted with posteromedial metal-on-metal contact and resulting knee varus.Damage to the articular tibial bearing.A definitive root cause cannot 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.

• Brand Name: VANGUARD CRUCIATE RETAINING FEMORAL COMPONENT RIGHT 70MM
• Type of Device: 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: 17905615
• MDR Text Key: 325338878
• Report Number: 0001825034-2023-02318
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 183012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 82 KG