MAUDE Adverse Event Report: CORIN MEDICAL TAPERFIT; TAPERFIT TOTAL HIP SYSTEM

Model Number 588.3802

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Fall (1848); Limb Fracture (4518)

Event Date 06/30/2022

Event Type  Injury  

Event Description

Taperfit / trinity revision of the stem, cement restrictor and mod head after approximately 2 years and 8 months due a periprosthetic fracture following a fall.

Manufacturer Narrative

Per (b)(4) initial report: additional information including operative notes, what the patient was doing when they fell, whether the patient followed the 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.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.

Manufacturer Narrative

Per -4841 final report.Additional information including operative notes, what the patient was doing when they fell, whether the patient followed the 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, not all information was available.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All finished parts associated with these records conformed to material and dimensional specification at the time of manufacture.The revision was required due to the patient falling and experiencing a femoral fracture and thus no further investigation is required.Therefore, this case is now considered closed.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 Description

Taperfit / trinity revision of the stem, cement restrictor and mod head after approximately 2 years and 8 months due a peri-prosthetic fracture following a fall.

• Brand Name: TAPERFIT
• Type of Device: TAPERFIT TOTAL HIP SYSTEM
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: dardan uka ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 14871549
• MDR Text Key: 295020289
• Report Number: 9614209-2022-00048
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K003666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/16/2022

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
• Device Operator: Health Professional
• Device Model Number: 588.3802
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 427506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 06/22/2022
• Supplement Dates FDA Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TAPERFIT CEMENT RESTRICTOR: 588.0002, 432715; TAPERFIT CEMENT RESTRICTOR: 588.0002, 432715; TRINITY CUP: 321.04.356, 432651; TRINITY CUP: 321.04.356, 432651; TRINITY ECIMA LINER: 322.04.636, 433621; TRINITY ECIMA LINER: 322.04.636, 433621; TRINITY MOD HEAD: E321.136, 399472; TRINITY MOD HEAD: E321.136, 399472
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 75 KG