MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACT ARTIC HD ARCOM XL 22X36MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	High metal ion levels (4847)
Date of Event	04/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer states that patient presented at follow up with elevated metal levels.Customer performed revision surgery to replace the dual mobility construct.It was noted during the revision surgery that liner appeared unaffected, and femoral head appeared affected.No additional information available at this time.
Additional Manufacturer Narrative
(b)(4).The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products(reported): (b)(6) g7 dual mobility liner 36mm b lot# 130980.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g3, g6, h1, h2, h3, h6, h10, h11.Visual examination of the provided pictures identified the head still within the bearing and the bearing outside of the metal liner.No visible damage can be seen on the components as noted.A review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility and it was determined that the following implants/instruments are not compatible: competitor head and our bearing.Medical records were not provided.Unable to confirm the event with the information provided.A definitive root cause cannot be determined, however per instructions for use- under the compatibility section 'do not use g7 dual mobility metal liners with components of any other system or manufacturer.' this is considered off label use, it is unknown if this off label use caused or contributed to the reported event.No corrective actions, preventive actions, or field actions resulted after the investigation of this event.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ACT ARTIC HD ARCOM XL 22X36MM
• 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: 19397359
• Report Number: 0001825034-2024-01360
• Device Sequence Number: 18083206
• Product Code: KWY
• UDI-Device Identifier: 00880304527416
• UDI-Public: (01)00880304527416(17)200722(10)718640
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K150522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

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 Expiration Date: 07/22/2020
• Device Model Number: N/A
• Device Catalogue Number: 010000993
• Device Lot Number: 718640
• 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: 04/26/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2015
• 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: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female