MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD CR TIB BRG 10X71/75; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	06/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01426.D10 medical devices: unknown right femoral cr catalog#: ni lot#: ni.Polished finned tib tray 71mm catalog#: 141253 lot#: 2018100120.G2 foreign source: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was discarded.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 patient underwent a right total knee arthroplasty.Subsequently, patient was revised for an unknown reason.Attempts have been made and no further information has been provided.
Event or Problem Description
It was reported that patient underwent a right total knee arthroplasty.Subsequently, patient was revised due to pain.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: a1, a2, a3, b4, g3, g6, h2, and h10.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: the reported event could not be confirmed due to limited information received.Radiographs were reviewed by a healthcare professional, which identified implant fit and alignment were maintained.Bone quality appeared osteopenic.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause could not 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: VNGD CR TIB BRG 10X71/75
• 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: 17208359
• Report Number: 0001825034-2023-01425
• Device Sequence Number: 5540159
• Product Code: JWH
• UDI-Device Identifier: 00880304271135
• UDI-Public: (01)00880304271135(17)250611(10)901560
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 10/09/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/11/2025
• Device Model Number: N/A
• Device Catalogue Number: 183440
• Device Lot Number: 901560
• 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: 06/07/2023
• Supplement Date Received by Manufacturer: 06/08/2023; 06/26/2023; 10/05/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 07/03/2023; 07/20/2023; 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2020
• 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: Required Intervention; Hospitalization
• Patient Sex: Female