MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET® 360 KNEE SYSTEM; PROTHESIS, KNEE

Catalog Number	185204
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530); High metal ion levels (4847)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient has metallosis in right knee approximately 10 years post implantation.No intervention has been reported to date.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
(b)(4).G2 foreign - italy.Customer has indicated that the product not be returned to zimmer biomet as it is still implanted.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: a1, a4, b5, b7, d6; g3; h2; h6.The following section was corrected: a2.
Event or Problem Description
It was reported patient shows increased levels of cobal and chromium which legal attributes to the total knee components.Attempts to obtain additional information have been made; however, no more is available at this time.
Event or Problem Description
No further information is 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; g3; h2; h6 - no devices were received; therefore the condition of the components is unknown.- review of the device history record identified no deviations or anomalies during manufacturing.- this device is used for treatment.- the reported products were reviewed for compatibility with no issues noted.-review of complaint history found no additional related issues for these items and the reported part and lot combinations.-the operative notes do not suggest any intra operative complications when the devices were implanted.Lab report (dated (b)(6)2021, (b)(6) 2022, (b)(6) 2023 and (b)(6) 2024) state that the cobalt and chromium levels were above the normal range.X-rays review state that there is persistent widening of femoral tibial joint space and mild calcifications within joint space.-root cause cannot be determined.-no corrective actions, preventive actions, or field actions resulted after investigation of this event.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® 360 KNEE SYSTEM
• Common Device Name: PROTHESIS, 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: 23973114
• Report Number: 0001825034-2026-00055
• Device Sequence Number: 15776852
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/29/2026

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: 02/24/2025
• Device Catalogue Number: 185204
• Device Lot Number: 843570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 01/13/2026; 06/01/2026; 06/25/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 02/02/2026; 06/24/2026; 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2015
• 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: UNKNOWN FEMUR; UNKNOWN FEMUR; UNKNOWN FEMUR.; UNKNOWN FEMUR.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 220 LB