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

Model Number	588.3803
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Fall (1848)
Date of Event	05/27/2025
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 weight, activity level and medical history, whether the patient followed correct post-op protocol, how many falls did the patient have and what were they doing at the time of the falls 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
Taperfit / trinity revision of the stem, ecima insert and modular head after approximately 2 years and 1 month due to loosening of the stem (patient had multiple falls).
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, whether the patient followed correct post-op protocol, how many falls did the patient have and what were they doing at the time of the falls and an update on the patient post revision, was requested in order to progress with the investigation of this event, however, none of this information was provided.It was reported that the patient is osteoporotic and had multiple falls post primary leading to the stem loosening.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.Review 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 has been concluded to be patient related conditions.The patient is osteoporotic and had multiple falls post primary surgery which resulted in the loosening of the taperfit stem and the subsequent revision.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 dual mobility revision of the stem, ecima insert and modular head after approximately 2 years and 1 month due to loosening of the stem (patient had multiple falls).

• 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: 22126224
• Report Number: 9614209-2025-00513
• Device Sequence Number: 7292376
• Product Code: JDI
• UDI-Device Identifier: 05055343868478
• UDI-Public: 05055343868478
• 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: 2023
• 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): 08/20/2025

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: 588.3803
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 503297
• 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: 05/27/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2022
• 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: TRINITY COCR MODULAR HEAD: E321.128, (B)(6).; TRINITY COCR MODULAR HEAD: E321.128, (B)(6).; TRINITY DM ECIMA INSERT: 325.03.040, (B)(6).
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female