MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD CR TIB BRG 14X63/67; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Pain (1994); Loss of Range of Motion (2032)
Date of Event	07/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Initial left total knee arthroplasty performed on an unknown date with unknown implants.Subsequently, the patient was revised due to instability.Approximately one year and eight months post revision , the patient was revised again due to pain.During the revision the tibial baseplate was found to be grossly loose with the implant delaminated from the underlying cobalt cement as well as varus angulation of the tibia secondary to progressive remodeling of the proximal tibial.It was determined that the patient would need a complete revision.All components were explanted without complications.
Additional Manufacturer Narrative
(b)(4).The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs: 141205 biomet tibial locking bar, lot# 515910.Mdr: 0001825034-2023-02535.Unk tibial.Mdr: 0001825034-2023-02540.Additional associated products: unk bone cement.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.  no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Insufficient information provided.Unable to perform a compatibility check.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: pain due to left tka; grossly loose tibial baseplate with the implant delaminated from the underlying cobalt cement; due to tibial baseplate being hung up on lateral femoral condyle and underlying instability, it was felt a full revision was necessary.Complaint is confirmed from provided medical records.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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: VNGD CR TIB BRG 14X63/67
• 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: 18021934
• Report Number: 0001825034-2023-02534
• Device Sequence Number: 18066476
• Product Code: HRY
• UDI-Device Identifier: 00880304271074
• UDI-Public: (01)00880304271074(17)230718(10)175710
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2024

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 Expiration Date: 07/18/2023
• Device Model Number: N/A
• Device Catalogue Number: 183424
• Device Lot Number: 175710
• 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: 10/06/2023
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2018
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female