MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX OPTION HEAD TAPER ADAPTER TYPE 1 SLEVE -3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
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
Event or Problem Description
It was reported that after right hip implantation three and a half years ago, 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 that his femur device contained aluminum.Patient was informed that he likely will require a revision to have the implant(s) removed.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).D10: 650-1055, cer bioloxd option hd 28mm, 2958695, 110024465, g7 dual mobility liner 46mm g, 416960, 010000667, g7 pps ltd acet shell 60g, 6736742, 192012, echo por fmrl nc12x140mm, 694410, 00-6250-065-25, trilogy bone scr 6.5x25, j6772010, 00-6250-065-20, trilogy bone scr 6.5x20, 64615053.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.
Additional Manufacturer Narrative
No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint histories identified additional similar complaints for the reported items and no additional similar complaints for the reported part and lot combinations.Complaints are monitored per complaint trending process.With the available information, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected and additional information.If any further information is found which would change or alter any conclusions or information, a supplemental report 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 three years and eight 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 that his femur device contained aluminum.There is no additional information available at the time of this report.

• Brand Name: BIOLOX OPTION HEAD TAPER ADAPTER TYPE 1 SLEVE -3
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 19357420
• Report Number: 3002806535-2024-00183
• Device Sequence Number: 15078181
• Product Code: LZO
• UDI-Device Identifier: 00887868248665
• UDI-Public: (01)00887868248665(17)290711(10)2989612
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K192683
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2024

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 650-1065
• Device Lot Number: 2989612
• 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: 07/05/2024; 10/30/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 07/12/2024; 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2019
• 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; Other
• Patient Sex: Male
• Patient Weight: 69 KG