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

Model Number	588.4500
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Taperfit / trinity revision of the stem, shell, ecima liner and biolox delta ceramic head after approximately 6 years and 2 months due to fracture of the stem.During the revision it was noted that there appeared to be infection.
Additional Manufacturer Narrative
Per - (b)(4) initial report.Additional information, including confirmation for the reason for revision, post primary and pre revision x-rays, operative notes (primary and revision), patient activity level, medical history and weight, whether the patient followed correct post-op protocol, whether the patient experienced any slips / falls or other trauma post primary surgery and an update on the patient post revision was requested.It was confirmed that the reason for revision was stem fracture with no apparent trauma and that infection was identified during the revision and thus this is the first stage of a two stage revision.The second stage is not yet planned.The patient was reported to be an active tennis player and it is unknown whether they followed correct post-op protocol.X-rays and op notes could not be provided.The appropriate device details have been provided and the relevant device manufacturing and sterilisation 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 occured 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 confirmation for the reason for revision, post primary and pre revision x-rays, operative notes (primary and revision), patient activity level, medical history and weight, whether the patient followed correct post-op protocol, whether the patient experienced any slips / falls or other trauma post primary surgery and an update on the patient post revision was requested.It was confirmed that the reason for revision was stem fracture with no apparent trauma and that infection was identified during the revision and thus this is the first stage of a two stage revision.The second stage is not yet planned.The patient was reported to be an active tennis player and it is unknown whether they followed correct post-op protocol.X-rays and op notes could not be provided.The reporter has stated that the stem did not have a very large cement mantle proximally which could have potentially been the cause of the stem fracture.The appropriate device details were provided and the relevant device manufacturing and sterilisation 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 not been determined.It is unknown what may have caused an infection so long after the initial implantation, however, the infection has not been linked to the corin devices.It is possible that cementing of the stem at primary surgery could have contributed to the stem fracture, however, this cannot be confirmed.No further investigation is possible and thus 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 occured 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, shell, ecima liner and biolox delta ceramic head after approximately 6 years and 2 months due to fracture of the stem.During the revision it was noted that there appeared to be infection.

• 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; GB GL7 1YJ
• Manufacturer Contact: franck didier ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 21924487
• Report Number: 9614209-2025-00487
• Device Sequence Number: 14508523
• Product Code: JDI
• UDI-Device Identifier: 05055343871072
• UDI-Public: 05055343871072
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K142761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• 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): 07/21/2025

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: 01/31/2023
• Device Model Number: 588.4500
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 377225
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2018
• 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: 104.3605, 386233; BIOLOX DELTA CERAMIC HEAD: 104.3605, 386233; TRINITY ECIMA LINER: 322.04.936, 380473; TRINITY ECIMA LINER: 322.04.936, 380473; TRINITY SHELL: 321.04.058, 374873; TRINITY SHELL: 321.04.058, 374873
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male