MAUDE Adverse Event Report: CORIN LTD TAPERFIT; TAPERFIT HIP STEM (1 HOLE)

Model Number	588.4503
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per (b)(4) initial report.The reporter has stated that they are unable to provide any further information on this event or the patient.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
Taperfit / trinity dual mobility revision of the stem, biolox delta ceramic head and ecima insert after approximately 4 months due to loosen cement mantle and thigh pain.
Additional Manufacturer Narrative
Per (b)(4) final report: the reporter stated that they were unable to provide any further information on this event or the patient.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.Reveiw of these records revealed no product non-conformity or deviation from process that would have caused or contributed to this event.Based on the available information, no further investigation can be conducted and the root cause of the event could not be determined.Therefore, this case is now considered closed, however, should any additional information be provided then this case may be re-opened for further investigation.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
Taperfit / trinity dual mobility revision of the stem, biolox delta ceramic head and ecima insert after approximately 4 months due to loose cement mantle and thigh pain.

• Brand Name: TAPERFIT
• Common Device Name: TAPERFIT HIP STEM (1 HOLE)
• 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: 23861814
• Report Number: 9614209-2025-00637
• Device Sequence Number: 9963471
• Product Code: JDI
• UDI-Device Identifier: 05055343868522
• UDI-Public: 05055343868522
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K142761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 03/04/2026

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: 588.4503
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 556808
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIOLOX DELTA CERAMIC HEAD: 104.2810, 590344.; BIOLOX DELTA CERAMIC HEAD: 104.2810, 590344.; TRINITY DM ECIMA INSERT: 325.04.042, 594625.; TRINITY DM ECIMA INSERT: 325.04.042, 594625.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 110 KG