MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VG 360 UNIV PST FM AUG 70X5; PROSTHESIS, KNEE

Catalog Number	185346
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) d10-medical product vngd ti fem ssk 70mm lt item# cp113127 lot# 795410, bmt splined knee stm v2 20x120 item# 148323 lot# 855010, biomet offset tibial tray 71mm item# 141483 lot# 866560, offset tib tray neut adaptor item# 141489 lot# 146410, bmt splined knee stm v2 20x80 item# 148310 lot# 102900.Unknown articular surface.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.
Event or Problem Description
It was reported that a patient is experiencing pain and ambulation difficulties approximately two years and two and a half months post implantation.Attempts to obtain additional information have been made; however, no more information is available at this time.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: a4, b4, b5, b7, d2, e1, e2, e3, e4, g1, g2, g3, g6, h1, h2, and h11.Correction: d6a.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
It was reported that a patient is experiencing pain and ambulation difficulties approximately two years and two and a half months post implantation.At follow-up visit a cortisone shot was offered and celebrex has been prescribed.Attempts to obtain additional information have been made; however, no more information is available.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, b7, d2, g1, g3, g6, h1, h2, h6, and h11.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, b7, d2, g1, g3, g6, h1, h2, h3, h6, and h11.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: ¿ motion has improved "she feels like she could have placed in her knee at all times.She is on pt.She tried compression sleeves, but nothing seems to be helping.She tried meloxicam which did not help," not calling out additional symptoms/outcomes as allegation is unclear from statement dictated.¿ incision c/d/i-no signs of infection, mild swelling within normal limits, rom 0-125deg.¿ patella tracks smoothly, excellent overall alignment, knee is stable.¿ overall patient is doing well.The feeling of a vice around her knee is very difficult to figure out.It is hard to tell if inflammation or just scar tissue present.A cortisone shot was offered, and celebrex has been prescribed.Radiograph report, three views of l knee.¿ excellent overall alignment.¿ no evidence of post-operative complications.¿ no evidence of early subsidence or loosening.¿ no evidence of fracture or implant complication.¿ normal appearing post-op total knee images.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.This complaint is confirmed through the medical records.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: VG 360 UNIV PST FM AUG 70X5
• 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: 21448147
• Report Number: 0001825034-2025-00439
• Device Sequence Number: 7158757
• Product Code: JWH
• UDI-Device Identifier: 00880304482470
• UDI-Public: (01)00880304482470(17)300720(10)138350
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K093293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 07/21/2025

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: Lay User/Patient
• Device Catalogue Number: 185346
• Device Lot Number: 138350
• 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: 02/03/2025
• Supplement Date Received by Manufacturer: 02/17/2025; 03/13/2025; 07/17/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 03/11/2025; 04/02/2025; 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2020
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 81 KG