MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA CER FEM HD 28/+3MM T1; HIP PROSTHESIS

Catalog Number	650-1157
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10 - associated medical devices: act artic e1 hip brg 28x40mm; item# ep-200146; lot# 094310.G2 - foreign: china.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that during the surgical procedure, the ceramic femoral head fractured.Both the ceramic head and the bearing were subsequently removed from the patient.Alternative products were used to successfully complete the surgery.Due diligence is in progress for this complaint; no further additional information or product has been received at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h6, h11.Visual inspection of the returned ceramic head confirmed the size and the presence of the ceramtec etching.The head was received seated within the polyethylene liner.Dark marks were observed around and inside the taper hole, consistent with metal transfer.The rim of the taper hole was found to be fractured, and one fractured piece was returned with the device.However, not all fragments were recovered.No additional damage was noted during the inspection.The component¿s properties and microstructure met production specifications, showing no pre-existing material defects.Secondary metal transfer marks were found on the femoral head fragments, likely from contact with metal parts or surgical instruments.Uneven primary metal transfer was observed on the bore surface.The fracture originated in region g, where adjacent metal transfer suggests a point or line contact with the metal stem taper.Additional metal transfer on the dome indicates contact with a metal object.The fracture likely resulted from high local stress caused by a point load¿possibly due to a tilted stem taper during impaction or repositioning.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 the part and lot combination.Complaints are monitored per complaint trending process in order to identify potential adverse trends.Regarding the fracture evaluation, the damage most likely resulted from high localized stress caused by a point load¿potentially from a tilted stem taper during impaction or repositioning.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 is available at the time of this report.

• Brand Name: BIOLOX DELTA CER FEM HD 28/+3MM T1
• 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
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22413327
• Report Number: 3002806535-2025-00249
• Device Sequence Number: 8407431
• Product Code: LZO
• UDI-Device Identifier: 00887868271519
• UDI-Public: (01)00887868271519(17)320405(10)3111362
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K200959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 650-1157
• Device Lot Number: 3111362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2022
• 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
• Patient Sex: Unknown