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

Model Number	588.3600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Taperfit revision of the stem and cement restrictor after approximately 3 months due to a peri-prosthetic fracture following a fall.
Additional Manufacturer Narrative
(b)(4) initial report.Additional information, including post primary and pre revision x-rays, operative notes (primary and revision), patient weight, activity level and medical history, what the patient was doing at the time of the fall, 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.
Additional Manufacturer Narrative
Per (b)(4) final report.Additional information, including post primary and pre revision x-rays, operative notes (primary and revision), patient weight, activity level and medical history, what the patient was doing at the time of the fall, whether the patient followed correct post-op protocol and an update on the patient post revision was requested in order to progress with the investigation of this event, however, this information was not provided and thus the scope of the investigation was limited.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.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, however, the peri-prosthetic fracture and subsequent revision occurred due to a patient fall it has been concluded that the event is not linked to the device design or performance.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 revision of the stem and cement restrictor after approximately 3 months due to a peri-prosthetic fracture following a fall.

• 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: 23825398
• Report Number: 9614209-2025-00621
• Device Sequence Number: 20107037
• Product Code: JDI
• UDI-Device Identifier: 05055343868454
• UDI-Public: 05055343868454
• 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): 02/23/2026

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: 588.3600
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 584817
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2025
• 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: TAPERFIT CEMENT RESTRICTOR: 588.0001, 596103; TAPERFIT CEMENT RESTRICTOR: 588.0001, 596103
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female