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

Model Number	588.3800
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Impingement (4834)
Date of Event	05/06/2025
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 age, activity level, weight and medical history, whether the patient followed correct post-op protocol, whether the patient experienced any slips / falls or other trauma post primary, what was implanted during the revision and an update on the patient following the 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 reviewwed.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 revision of the stem, cup, ecima liner, biolox delta ceramic head and 2 screws after approximately 4 years and 10 moths due to impingement.
Additional Manufacturer Narrative
(b)(4) final report additional information, including post primary and pre revision x-rays, operative notes (primary and revision), patient age, activity level, weight and medical history, whether the patient followed correct post-op protocol, whether the patient experienced any slips / falls or other trauma post primary, what was implanted during the revision and an update on the patient following the revision, was requested in order to progress with the investigation of this event, however, none of the information was provided.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewwed.All parts associated with these records conformed to material and dimensional specification at the time of manufacture.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.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 revision of the stem, cup, ecima liner, biolox delta ceramic head and 2 screws after approximately 4 years and 10 moths due to impingement.

• Brand Name: TAPERFIT
• Common Device Name: TAPERFIT 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: 22124072
• Report Number: 9614209-2025-00506
• Device Sequence Number: 21006907
• Product Code: JDI
• UDI-Device Identifier: 05055343871065
• UDI-Public: 05055343871065
• 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: 2021
• 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): 08/04/2025

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 Expiration Date: 11/05/2024
• Device Model Number: 588.3800
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 435651
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2019
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 104.3605, 479695.; BIOLOX DELTA CERAMIC HEAD: 104.3605, 479695.; TRINITY ECIMA LINER: 322.03.936, 474885.; TRINITY ECIMA LINER: 322.03.936, 474885.; TRINITY-I CUP: 321.03.350, 468972.; TRINITY-I CUP: 321.03.350, 468972.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown