MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA CER OPTION HD 36MM; PROSTHESIS, HIP

Catalog Number	650-1057
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	10/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - associated medical devices: unknown biolox taper sleeve; item# unknown; lot# unknown.Unknown taperloc stem; item# unknown; lot# unknown.Unknown g7 liner; item# unknown; lot# unknown.Unknown g7 osseo ti shell; item# unknown; lot# unknown.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 approximately three years and six months post an initial right total hip arthroplasty, the patient underwent a revision surgery due to a fractured femoral ceramic head.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information is available 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, g3, g6, h2, h11.Upon further investigation of the reported event, it was determined that this event had already been reported under medwatch report id: 3002806535-2025-00515.Therefore, as this report is considered a duplicate, it will be voiding, and all future reporting related to this event will be conducted under medwatch report id: 3002806535-2025-00515.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.

• Brand Name: BIOLOX DELTA CER OPTION HD 36MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA
• 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: 24481793
• Report Number: 3002806535-2026-00103
• Device Sequence Number: 10126378
• Product Code: LZO
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K200959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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: 650-1057
• Device Lot Number: 3079982
• 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: 02/04/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2021
• 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: Unknown