MAUDE Adverse Event Report: CORIN MEDICAL MINI HIP; MINI HIP STEM SIZE 3

Model Number 580.0003

Device Problem Material Integrity Problem (2978)

Patient Problem Joint Laxity (4526)

Event Date 02/24/2021

Event Type  Injury  

Event Description

Mini hip revision after approximatively 4 years due to fracture of the stem.

Manufacturer Narrative

Per (b)(4) initial report: additional information, patient age and activity level and medical history, update of the patient post revision and if the patient experienced any trauma prior to the revision, has been requested in order to progress with this investigation, and if received, will be provided in a supplemental report up completion of the investigation.Clarification whether the affected device can be returned to corin was requested.The appropriate devices 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 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.

Manufacturer Narrative

(b)(4) - final report.This is a duplicate of the per (b)(4) (mfr report 9614209-2021-00052).Corin now considers this case withdrawn.Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa,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 Description

Mini hip revision after approximatively 4 years due to fracture of the stem.

• Brand Name: MINI HIP
• Type of Device: MINI HIP STEM SIZE 3
• 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: 15359651
• MDR Text Key: 299309534
• Report Number: 9614209-2022-00093
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K111046
• 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 Expiration Date: 12/21/2021
• Device Model Number: 580.0003
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 344900
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/06/2022
• Supplement Dates Manufacturer Received: 08/31/2022
• Supplement Dates FDA Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: BIOLOX MOD HEAD 104.3610 LOT 336964; BIOLOX MOD HEAD 104.3610 LOT 336964; TRINITY CUP 321.04.058 LOT 345664; TRINITY CUP 321.04.058 LOT 345664; TRINITY ECIMA LINER 322.04.636 LOT 347335; TRINITY ECIMA LINER 322.04.636 LOT 347335
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male