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

Model Number	588.4502
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unequal Limb Length (4534)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per (b)(4) initial report.Additional information including post primary and pre revision x-rays, operative notes (primary and revision), patient activity level, medical history and weight, what was implanted during the revision, confirmation of the device lot codes, primary surgery update, whether the leg length / offset differences have been addressed 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 for the stem have been provided and the relevant device manufacturing record will be identified and reviewed.Upon receipt of the lot code of the trinity biolox delta ceramic head the relevant device manufacturing record 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 and biolox delta ceramic head due to a leg length discrepancy.
Additional Manufacturer Narrative
(b)(4) final report additional information including post primary and pre revision x-rays, operative notes (primary and revision), patient activity level, medical history and weight, what was implanted during the revision, confirmation of the device lot codes, primary surgery update, whether the leg length / offset differences have been addressed and an update on the patient post revision was requested in order to progress with the investigation of this event, however, this information has not been provided and thus the scope of the investigation was limited.The appropriate device details for the stem were provided and the relevant device manufacturing record has been identified and reviewed.All parts associated with this record conformed to material and dimensional specifictaion at the time of manufacture.The lot code for the revised head has not been provided and thus this manufacturing record could not be identified or reviewed.Based on the available information, no further investigation can be conducted.It is likely that choice the implant size / offset used at primary surgery caused the leg length discrepancy.The root cause has not been directly linked to the device design or performance 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 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 and biolox delta ceramic head due to a leg length discrepancy.
Additional Manufacturer Narrative
Per (b)(4) final report.Additional information including post primary and pre revision x-rays, operative notes (primary and revision), patient activity level, medical history and weight, what was implanted during the revision, confirmation of the device lot codes, primary surgery update, whether the leg length / offset differences have been addressed and an update on the patient post revision was requested in order to progress with the investigation of this event, however, not all of this information has been 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 specifictaion at the time of manufacture.Based on the available information, no further investigation can be conducted.It is likely that choice the implant size / offset used at primary surgery caused the leg length discrepancy.The root cause has not been directly linked to the device design or performance 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 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 and biolox delta ceramic head due to a leg length discrepancy.

• 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: 24269318
• Report Number: 9614209-2026-00014
• Device Sequence Number: 15967276
• Product Code: JDI
• UDI-Device Identifier: 05055343868515
• UDI-Public: 05055343868515
• 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: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2026

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: 588.4502
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 512724
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 01/29/2026; 01/29/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 04/28/2026; 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/23/2022
• 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: BIOLOX DELTA CERAMIC HEAD: 104.3615, 547771.; BIOLOX DELTA CERAMIC HEAD: 104.3615, LOT UNKNOWN.; BIOLOX DELTA CERAMIC HEAD: 104.3615, LOT UNKNOWN.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male