MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FMRL NC 12X140MM; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Pain (1994); Lymphoma (3263); Swollen Lymph Nodes/Glands (4432); Metal Related Pathology (4530); High White Blood Cell Count (4594)
Date of Event	08/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 010000667 , item name: g7 pps ltd acet shell 60g, lot # 6736742; 110024465, item name: g7 dual mobility liner 46mm g, lot # 416960.The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that after implantation, the patient had ongoing pain.Patient started having swollen lymph nodes and high white blood cell count more recently.Patient was diagnosed with chronic lymphocytic leukemia and marginal lymphoma in the groin only.Patient is receiving ongoing diagnostics.Patient was told he had heavy metal poisoning to aluminum and several other metals.The implant surgeon¿s office informed the patient today that his femur device contained aluminum.Patient was informed that he likely will require a revision to have the implants removed.There is no additional 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/corrected updated: b3, b4, b5, d6b, e1, g3, g6, h2, h6: proposed component code: mechanical (g04) stem h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.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 for the metal related pathology.No problem was found with the devices after review by a hcp and the provided biocompatibility memo.This complaint cannot be 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.
Event or Problem Description
It was reported that the patient underwent a revision procedure 3 years and 8 months post implantation as the patient had ongoing pain.Patient started having swollen lymph nodes and high white blood cell count more recently.Patient is receiving ongoing diagnostics.Patient was told he had heavy metal poisoning to aluminum and several other metals.The implant surgeon¿s office informed the patient today that his femur device contained aluminum.Patient was informed that he likely will require a revision to have the implants removed.There is no additional information available at the time of this report.

• Brand Name: ECHO POR FMRL NC 12X140MM
• Common Device Name: PROSTHETIC, HIP
• 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: 19351828
• Report Number: 0001825034-2024-01282
• Device Sequence Number: 7403423
• Product Code: KWA
• UDI-Device Identifier: 00887868260438
• UDI-Public: (01)00887868260438(17)300218(10)694410
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K070274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 192012
• Device Lot Number: 694410
• 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: 04/23/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2020
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 69 KG