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	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 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 the during the surgery, the doctor successfully repositioned the bearing trial mold and ceramic head trial mold.However, when assembling the prosthesis with the ceramic head and bearing, the ceramic head fractured during repositioning.Despite attempts to remove it, the head was stuck inside the bearing, and both components were replaced with new products.Due diligence is in progress for this event; to date no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay corrected information.The following sections were updated: b4, b5, g3, g6, h2, h10, h11.The incident reported under (b)(4) , mfr report number: 3002806535-2025-00253, can be closed as a duplicate of the complaint (b)(4) , mfr report number: 3002806535-2025-00249.
Event or Problem Description
The incident reported under (b)(4), mfr report number: 3002806535-2025-00253, can be closed as a duplicate of the complaint (b)(4), mfr report number: 3002806535-2025-00249.

• 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 CF31 3XA; UK CF31 3XA
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22434292
• Report Number: 3002806535-2025-00253
• Device Sequence Number: 11929683
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2025

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: Health Professional
• Device Catalogue Number: 650-1157
• Device Lot Number: 3111362
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown