MAUDE Adverse Event Report: CORIN LTD METAFIX; METAFIX HIP STEM

Model Number	579.2102
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) initial report.Additional information, including post primary and pre revision x-rays, operative notes (primary and revision), patient activity level, weight and medical history, whether the patient followed correct post-op protocol 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.
Event or Problem Description
Metafix / trinity revision of the stem, ecima liner and biolox delta ceramic head after approximately 10 months and 2 weeks due to subsidence / loosening of the stem.
Additional Manufacturer Narrative
(b)(4).Final report.Photographs of the parts explanted and x-rays have been communicated by the reporter in order to progress with this investigation.The appropriate device details were provided.The relevant device manufacturing records have been identified and reviewed.All finished parts associated with these records conformed to material and dimensional specifications at the time of manufacture.Based on the investigation, a stem was implanted that was 3 sizes below opsinsight planning.Thus, the root cause was due to an undersized stem.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.
Event or Problem Description
Metafix / trinity revision of the stem, ecima liner and biolox delta ceramic head after approximately 10 months and 2 weeks due to subsidence / loosening of the stem.

• Brand Name: METAFIX
• Common Device Name: METAFIX HIP STEM
• 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: 22095058
• Report Number: 9614209-2025-00501
• Device Sequence Number: 8059839
• Product Code: LZO
• UDI-Device Identifier: 05055343891452
• UDI-Public: 05055343891452
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K153381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 579.2102
• Device Lot Number: 561648
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2024
• 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: BIOLOX DELTA CERAMIC HEAD: 104.3615, (B)(6).; BIOLOX DELTA CERAMIC HEAD: 104.3615, (B)(6).; TRINITY ECIMA LINER: 322.05.636, (B)(6).; TRINITY ECIMA LINER: 322.05.636, (B)(6).
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male