MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET FINNED PRI STEM 40MM; PROSTHESIS, KNEE

Catalog Number	141314
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10- medical product: vanguard cr ilok fem-rt 62.5, item# 183006, lot# j6178746.Vngd cr tib brg 10x63/67, item# 183420, lot# 911740.Biomet ilok pri tib tray 67mm, item# 141212, lot# 982290.Series a pat std 31 3 peg, item# 184764, lot# 833420.H3- customer has indicated that the product will 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.Proposed annex g code: mechanical (g04) ¿ stem.
Event or Problem Description
It was reported that a patient was revised approximately seven years seven and a half months post implantation due to collapse of the implant on one side causing pain.Attempts to obtain additional information have been made; however, no more information is available at this time.
Event or Problem Description
It was reported that a patient was revised approximately seven years seven and a half months post implantation due to collapse of the implant on one side causing pain.The patient experienced pain when bearing weight on the operative knee, pain when walking, inability to climb or descend stairs due to significant pain.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.Updated: b3, b4, b5, b7, d2b, d4, d6a, d9, g1, g3, g6, h1, h2, h3, h4, h6, and h11.D6a.Initial surgery: (b)(6) 2018.Visual examination of the returned devices identified signs of use with gouges, bio-debris present and wear caused by contact with the femoral component the associated locking bar also exhibited signs of use (gouges) and the tab was bent.Sem analysis identified that the locking pin was also returned; the spring arm on the pin was bent, most likely due to explanation damage.The locking mechanism of the bearing was intact, by laying the bearing in place atop the tibial tray, it could be seen that the damage to the left-hand condyle posterior side aligns with damage to the tibial tray.Dimensional analysis of the tibial tray and locking bar determined that the products, where measured, were conforming to print specifications.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.This complaint is confirmed.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.

• Brand Name: BIOMET FINNED PRI STEM 40MM
• 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: 23933825
• Report Number: 0001825034-2025-04247
• Device Sequence Number: 13143563
• Product Code: JWH
• UDI-Device Identifier: 00880304006706
• UDI-Public: (01)00880304006706(17)280220(10)138020
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 141314
• Device Lot Number: 138020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2018
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 102 KG