MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD BMT GB KNEE STM 12X80; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Muscle Weakness/Atrophy (1967); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Balance Problems (4401); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a knee surgery and approximately 3 months post-op, the patient was diagnosed with patellar tendonitis and received a steroid injection.The patient continued to have ongoing issues with pain, swelling, quadricep weakness/atrophy, balance deficits, and limited range of motion.Additional courses of physical therapy were prescribed without resolution.The patient does not want to undergo another revision and has continued to seek help for ongoing symptoms.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 00542000800 - all poly patella size 0 8 mm thickness - 64212622.00585204025 - stem collar 25 mm o.D.For use with 16 mm or smaller diameter segmental stems - 64243673.5036964 - heraeus medical cement w/gent high viscocity - 93564861.183302 - vngd ssk psc intlk fmrl 60 rt - 605140.183824 - vngd sskpsc tib brg s 14x63/67 - 636650.185201 - bmt 360 tib tray 63mm - 897880.130615 - intramedullary plug xl - 685630.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6.H6: mechanical (g04) stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Office notes post-surgery state patient still has pain, swelling and range of motion issues.Patient is also experiencing knee weakness which has limited her functional mobility.A definitive root cause cannot 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.

• Brand Name: VANGUARD BMT GB KNEE STM 12X80
• 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: 19604392
• Report Number: 0001825034-2024-01671
• Device Sequence Number: 15283217
• Product Code: JWH
• UDI-Device Identifier: 00880304476417
• UDI-Public: (01)00880304476417(17)291107(10)153050
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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: 148162
• Device Lot Number: 153050
• 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: 05/31/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 69 KG