MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VG CR MONO-LCK BRG 10X67; PROSTHESIS, KNEE

Model Number	189640
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial right total knee arthroplasty.Subsequently, approximately two years and five months post implantation, the surgeon has identified catastrophic failure of the polyethylene component.X-ray images have revealed poly component wear.A revision surgery is not currently planned.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Concomitant medical product: vanguard cr interlok fem - rt 60: catalog#183004, lot#j6576760; vg crl mono-lck brg 10x67: catalog#189240, lot#520450; unknown cement: catalog#ni, lot#ni.Report source: foreign: (b)(6).Customer has indicated that product will not be returned to zimmer biomet for investigation, as the product currently remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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.Primary operative notes state no intra-op complications.X-ray review by third party states that the right total knee arthroplasty demonstrates significant joint space loss in the medial compartment with metal on metal contact which suggests poly wear.The lateral compartment appears grossly unremarkable.No periprosthetic or osseous abnormalities.Root cause was unable to be determined.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.
Event or Problem Description
No further event information at time of this report.

• Brand Name: VG CR MONO-LCK BRG 10X67
• 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: 14712326
• Report Number: 0001825034-2022-01411
• Device Sequence Number: 2265039
• Product Code: JWH
• UDI-Device Identifier: 00880304555983
• UDI-Public: (01)00880304555983(17)200729(10)520450
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/29/2020
• Device Model Number: 189640
• Device Catalogue Number: 189640
• Device Lot Number: 520450
• 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: 06/04/2022
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2015
• 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: Other
• Patient Age: 64 YR
• Patient Sex: Male