MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA CERAMIC FEM HD 36/0MM; HIP PROSTHESIS

Catalog Number	650-0661
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item name: g7 osseoti 4 hole shell 58mm g; item number: 110010247; lot number: 66928198.Item name: g7 vit e neutral lnr 36mm g; item number: 30103607; lot number: 66156543.Item name: 3.2mmx30mm rnglc+ acet drl bit; item number: 31-323230; lot number: 66874960.Item name: trilogy bone scr 6.5x25; item number: 00-6250-065-25; lot number: j7746386.Item name: tprlc 133 t1 pps so 13x146mmtp; item number: 51-103130; lot number: 6674058.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient underwent hip revision surgery due to fracture of the ceramic femoral head, approximately 40 days post-implantation.Attempts have been made and all additional information received has been included in this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.No product was returned; therefore, a product evaluation could not be performed.Pictures provided shows the ceramic head is fractured into three parts.The taper connection exhibits some metal smearing; however, the seating of the head on the stem cannot be evaluated from the available images.The removed insert is also shown with some screws, with one screw head appearing to be broken off.These screws were most likely used for removal of the insert.The insert¿s articulation surface shows an indentation of the stem, which appears to have occurred after the fracture of the head.The stem taper is also shown in one of the pictures and seems to be worn.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.Radiographs of the right hip were provided and reviewed, including two views: one showing the fractured head and one taken prior to the fracture.The review identified a right total hip arthroplasty with fracture of the femoral head and separation of the femoral head and neck of the arthroplasty.The implant fracture is identified.The other radiographs show the correct implantation of the implants.Based on the available information, the reported event can be confirmed.However, 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. .

• Brand Name: BIOLOX DELTA CERAMIC FEM HD 36/0MM
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21899163
• Report Number: 3002806535-2025-00169
• Device Sequence Number: 3442528
• Product Code: LZO
• UDI-Device Identifier: 00887868271175
• UDI-Public: (01)00887868271175(17)340923(10)3215969
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 08/21/2025

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 Catalogue Number: 650-0661
• Device Lot Number: 3215969
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male