MAUDE Adverse Event Report: Corin Ltd BIOLOX Delta; BIOLOX Delta Femoral Heads

Model Number	104.2805
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Unequal Limb Length (4534)
Date of Event	09/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Paragon / trinity dual mobility revision (with ops used in primary) of the stem, ecima insert and biolox delta ceramic head after nearly 3 months due to a leg length discreapancy following a femoral fracture (with stem subsidence) and previous surgery to plate and cable the femur.Please note: the paragon stem associated with this report (gm08001-202-05) is not cleared for sale / distribution in the usa and this event occurred outside of the usa.
Additional Manufacturer Narrative
Per (b)(4) initial report additional information including date of the procedure where the femur was plated and cabled, why was the stem not revised at this point if it was identified to have subsided, when was the leg length discrepancy identified, is it believed that this was a result of the stem subsidence, patient activity level, weight and medical history, post primary and pre-revision x-rays, operative notes (primary and revision), whether the patient followed correct post-op protocol, whether the patient experienced any slips / falls or other trauma and an update on the patient post revision, has been requested in order to progress with the investigation of this event, and if received, will be provided in a supplemental report upon completion of the investigation.The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed.Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.

• Brand Name: BIOLOX Delta
• Common Device Name: BIOLOX Delta Femoral Heads
• Manufacturer (Section D): Corin Ltd; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): Corin Ltd; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: franck didier ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 50800458
• Report Number: 9614209-2026-00120
• Device Sequence Number: 10590167
• Product Code: LZO
• UDI-Device Identifier: 05055196964327
• UDI-Public: 05055196964327
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103120
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 104.2805
• Device Catalogue Number: Not applicable
• Device Lot Number: 620985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OPS Acetabular Guide: 1248-0500, MNC_SC_40084; OPS Femoral Guide: 1250-0100, MNC_SC_40084; OPS Insight: 1200-0000, MNC_SC_40084; Paragon Stem: GM08001-202-05; Trinity DM ECiMa Insert: 325.03.040, 616699
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male