MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CR ILOK FEM-LT 65; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised approximately five years and nine months post implantation due to instability.There is no additional information available.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2024-00699.D10-medical product: vngd ant stblzd brg 20x75, item# 189090, lot# 072710.Bmt splined knee stm v2 13x160, item# 148327, lot# 600100.Vg 360 dst fm ag 70x10 rl/lm, item# 185386, lot# 66059614.Vg 360 dst fm ag 70x10 ll/rm, item# 185406, lot# 66044535.Vg 360 univ pst fm aug 70x5, item# 185346, lot# 66303815.Vngd ssk psc tib brg 16x71/75, item# 183886, lot# 66280240.Biomet tibial locking bar, item# 141205, lot# 66177055.H3- customer has indicated that the product will not 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.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.No product was returned, or no photographs were provided; therefore, visual and dimensional evaluations could not be performed.X-ray review by mmi states that left total knee arthroplasty with large polyethylene liner but otherwise no abnormality seen.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.Root cause cannot be determined.This complaint cannot be confirmed.If any further information is received which would change or alter any conclusions or information, a supplemental medwatch 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: VANGUARD CR ILOK FEM-LT 65
• 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: 18933812
• Report Number: 0001825034-2024-00698
• Device Sequence Number: 18503163
• Product Code: JWH
• UDI-Device Identifier: 00880304270510
• UDI-Public: (01)00880304270510(17)280105(10)J6176789
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 183028
• Device Lot Number: J6176789
• 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: 02/21/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2018
• 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; Hospitalization; Required Intervention; Required Intervention
• Patient Sex: Female