MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VGD PS OPEN POR FEM RT 57.5; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: vngd ps tib brg 12x63/67mm, item# 183622, lot# 901270; biomet cc cruciate tray 67mm, item# 141232, lot# j6802299.Report source - (b)(6).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 six and a half months post implantation due to femoral loosening.The original tibial component is still in situ.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: b3, b4, b5, g3, g6, h1, h2, and h10.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Visual examination of the returned femoral component found signs of being implanted and a lack of bone ingrowth.X-rays were provided and reviewed by a health care professional.Review found anatomic alignment of the right knee arthroplasty.There is no sign of implant loosening.Bone quality is osteopenic.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: VGD PS OPEN POR FEM RT 57.5
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12619692
• Report Number: 0001825034-2021-02849
• Device Sequence Number: 1348935
• Product Code: JWH
• UDI-Device Identifier: 00880304442269
• UDI-Public: (01)00880304442269(17)280423(10)575540
• 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: 2021
• Device Explanted Year: 2021
• 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): 02/16/2022

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: 184502
• Device Lot Number: 575540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• 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: 10/04/2021
• Supplement Date Received by Manufacturer: 10/11/2021; 02/10/2022
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 10/21/2021; 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2018
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown