MAUDE Adverse Event Report: Biomet UK Ltd. DELTA CER FEM HD 32/0MM T1; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer

Catalog Number	650-1162
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent hip revision surgery due to a fractured femoral head.No known trauma or other contributing factors were identified.A revision procedure involving replacement of the femoral head only has already been performed.Attempts have been made, and all additional information received has been included in this report.
Additional Manufacturer Narrative
(b)(4).D10: item name# allofit alloclas shell 52/ii; item number# 4245; lot number# 3276928 item name# dural alpha insert neutr ii/32; item number# 01.00013.409; lot number# 3267557 item name# tprlc 133 t1 pps ho 15x150mm; item number# 51-104150; lot number# j8086382 g2: foreign - event occurred in the netherlands.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.

• Brand Name: DELTA CER FEM HD 32/0MM T1
• 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50753246
• Report Number: 3002806535-2026-00339
• Device Sequence Number: 9195220
• Product Code: LZO
• UDI-Device Identifier: 00887868271564
• UDI-Public: (01)00887868271564(17)360414(10)3271448
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K200959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: 650-1162
• Device Lot Number: 3271448
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown