MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD PS OPEN POR FMRL LT 62.5; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2022-02215 initial surgery took place in (b)(6) 2022.Medical product: biomet cc cruciate tray 71mm item# 141233 lot# j7110137, vngd ps tib brg 12x71/75mm item# 183642 lot# 779270.Customer has indicated that the product will 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 a patient was revised approximately seven months post implantation due to subsidence and device migration.During surgery, the physician established that the femoral component had not grown in and also observed a malrotation of the tibial component.Attempts to obtain additional information have been made; however, no more information is available at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, d6a., g3, g6, h1, h2, and h10.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Visual examination of the returned item found it to exhibit signs of use with femoral with surface scratches and tibia with surface scratches and bone cement remains.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: initial op notes found no intraoperative complication.Review of x-ray found left total knee arthroplasty with loosening of the femoral component and possible early loosening and rotation of the tibial component.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.If any further information is which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.H6: component code: proposed component (annex g) code is: mechanical (g04) -femur.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: VNGD PS OPEN POR FMRL LT 62.5
• 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: 15500898
• Report Number: 0001825034-2022-02216
• Device Sequence Number: 1793114
• Product Code: JWH
• UDI-Device Identifier: 00880304441705
• UDI-Public: (01)00880304441705(17)291004(10)888140
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted 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,Followup
• Report Date (Section B): 02/14/2023

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: 184526
• Device Lot Number: 888140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/19/2022
• Supplement Date Received by Manufacturer: 10/07/2022; 01/30/2023
• Initial Report FDA Received Date: 09/28/2022
• Supplement Report FDA Received Date: 10/26/2022; 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2019
• 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 Sex: Unknown