MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD SERIES A PAT THIN 37X8.6 3 PEG; PROSTHESIS, KNEE

Catalog Number	184788
Medical Device Problem Codes	Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577); Aseptic loosening (4883); Arthrofibrosis (4885); Crepitus (4893)
Date of Event	08/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 189120 - vngd ant stblzd brg 10x83 - (b)(6).Unknown - unknown femoral component - unknown.Unknown - unknown tibial component - unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial knee surgery.Approximately 3 months post-op, the patient underwent a right knee revision due to pain, swelling, and patellar loosening.The patella and poly were revised.
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 the event cannot be confirmed.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.Medical records were not provided.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.
Event or Problem Description
It was further reported that a patient had an initial right total knee arthroplasty performed.Subsequently, the patient was revised approximately 3 months post-op due to pain, swelling, and stiffness.During the revision, abundant scar tissue was removed, and the patellar button was found displaced with shearing through all three of the pegs.The patella was revised without complications.The bearing was also replaced and downsized to reduce tension within the joint.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a1; a2; a3; a4; a5; b4; b5; b7; d2; d10; e1; g1; g3; g6; h1; h2; h6.D10: 189120 - vngd ant stblzd brg 10x83 - 764490.183014 - vanguard cr ilok fem-rt 75 - j7030081.141236 - biomet cc cruciate tray 83mm - j7053597.110035368 - biomet bc r 1x40 us - az43aj2201.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6; h10.The event is confirmed.Medical records provided and reviewed by a healthcare professional.Review of the records state that a patient underwent a right tka and the contributing factor for the procedure was bilateral knee degenerative joint disease (djd).No intraoperative complications were identified.Medical records further state that the patient was subsequently revised due to complaints of pain, swelling, and stiffness.Imaging confirmed displacement of the patellar button.Intraoperatively, abundant scar tissue and arthrofibrosis were identified throughout the knee, along with a hypertrophic anterior scar.The surgeon also notes stiffness and decreased rom.The patellar button was found loose within the joint, with shearing through all three pegs.The bearing was exchanged and downsized to reduce joint tension.The new bearing was locked into place and the new patellar button was cemented without intraoperative complications.The femoral and tibial components were retained.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: VANGUARD SERIES A PAT THIN 37X8.6 3 PEG
• 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: 23027975
• Report Number: 0001825034-2025-02882
• Device Sequence Number: 13118621
• Product Code: JWH
• UDI-Device Identifier: 00887868344169
• UDI-Public: (01)00887868344169(17)260312(10)189710
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/06/2026

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: Lay User/Patient
• Device Expiration Date: 03/12/2026
• Device Catalogue Number: 184788
• Device Lot Number: 189710
• 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: 08/28/2025
• Supplement Date Received by Manufacturer: 12/08/2025; 02/13/2026; 04/06/2026
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 12/08/2025; 02/24/2026; 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2021
• 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.; SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 176 KG
• Patient Ethnicity: Hispanic
• Patient Race: White