MAUDE Adverse Event Report: CORIN LTD TRINITY; BIOLOX DELTA CERAMIC MODULAR HEAD Ø36MM 12/14 MEDIUM 0,

Model Number	104.3605
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Granuloma (1876); Insufficient Information (4580)
Date of Event	03/31/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per (b)(4) - initial report.Additional information, including event, dates of implantation and confirmation of the date of explantation, confirmation of the part numbers and lot codes, x-rays, operative notes, patient medical information, 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 requested 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 occured 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.
Event or Problem Description
Dynacup and biolox delta revision of the cup, insert and head (failure mode to be confirmed -> complementary info requested).Note: cup and insert are not cleared in the usa.
Event or Problem Description
Dynacup and biolox delta revision of the cup, insert and head after approximatively 7 years due to granuloma.Note 1: cup (hlm629) and insert (hzl104) are not cleared in the usa.Note 2: following feedback from the reporter, the part number of the head is hzl027 and not 104.3605 as initially reported.This is not cleared in the usa, consequently this report can be cancelled.
Additional Manufacturer Narrative
Per (b)(4) final report.Additional information regarding part numbers was provided.This allowed us to identify that the part number of ceramic head as reported in the initial report was not correct.Note 1: cup (hlm629) and insert (hzl104) are not cleared in the usa, as initially reported.Note 2: following feedback from the reporter, the part number of the head is hzl027 and not 104.3605 as initially reported.This is not cleared in the usa, consequently this report can be cancelled.Consequently, corin consider now this case closed.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 occured 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: TRINITY
• Common Device Name: BIOLOX DELTA CERAMIC MODULAR HEAD Ø36MM 12/14 MEDIUM 0,
• 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: 24844520
• Report Number: 9614209-2026-00046
• Device Sequence Number: 15684956
• Product Code: LZO
• UDI-Device Identifier: 05055196964389
• UDI-Public: 05055196964389
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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: 104.3605
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: TO BE CONFIRMED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: DYNACUP / CUP: HLM629 LOT 415553.; DYNACUP / CUP: HLM629 LOT 415553.; DYNACUP / INSERT: HZL104 LOT TBC.; DYNACUP / INSERT: HZL104 LOT TBC.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female