MAUDE Adverse Event Report: CORIN MEDICAL MINI HIP; MINI HIP STEM SIZE 6

Model Number 580.0006

Device Problem Material Integrity Problem (2978)

Patient Problem Joint Laxity (4526)

Event Date 08/21/2022

Event Type  Injury  

Event Description

Mini hip revision after approximatively 11 years due to fracture of the stem.

Manufacturer Narrative

Per 5017 fda final report: additional information, including x-rays, operative notes, patient activity level and medical history, update of the patient post revision and if the device is available for examination, 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.The appropriate device details have been provided and 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 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

Per 5017 fda final report.Additional information, including x-rays, operative notes, patient activity level and medical history, update of the patient post revision and if the device is available for examination, has been requested in order to progress with this investigation, however this information was not provided.The appropriate device details have been provided and the relevant device manufacturing record has been identified and reviewed.All finished parts associated with this record conformed to material and dimensional specifications at the time of manufacture.Based on the above, no further investigation can be conducted, and the root cause of the reported breakage could not be determined.Therefore, 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 Description

Mini hip revision after approximatively 11 years due to fracture of the stem.

Event Description

Mini hip revision after approximatively 11 years due to fracture of the stem.

Manufacturer Narrative

Per 5017 fda final report (update): additional information, including x-rays, operative notes, patient activity level and medical history, update of the patient post revision and if the device is available for examination, has been requested in order to progress with this investigation, however this information was not provided.The appropriate device details have been provided and the relevant device manufacturing record has been identified and reviewed.All finished parts associated with this record conformed to material and dimensional specifications at the time of manufacture.The explanted stem was returned to corin and reviewed.It has a damaged fracture surface and is visibly very scratched, therefore it is not possible to identify the crack initiation point.It can be concluded that the neck finally failed with a rapidly propagating fracture, probably from the top to the bottom of the neck, after approximately 11 years of implantation causing the neck and body of the stem to disassociate.A root cause could not be fully identified as no information about the original implantation (x-ray), patient characteristics (size, weight, activity levels) or whether any trauma had previously occurred was provided.This case is now considered closed.Should any additional information be provided then this case may be re-opened for further investigation.Please note: a final report has already been submitted in nov 2022.This case has been reopened following the return to corin of the explanted device.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.

• Brand Name: MINI HIP
• Type of Device: MINI HIP STEM SIZE 6
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester GL7 1 YJ,; UK GL7 1YJ,
• Manufacturer (Section G): CORIN MEDICAL; the corinium centre; cirencester GL7 1 YJ,; UK GL7 1YJ,
• Manufacturer Contact: dardan uka ; the corinium centre; cirencester, GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 15319405
• MDR Text Key: 298873065
• Report Number: 9614209-2022-00086
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K083312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2023

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: 04/30/2015
• Device Model Number: 580.0006
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 167104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/29/2022
• Initial Date FDA Received: 08/30/2022
• Supplement Dates Manufacturer Received: 08/29/2022; 08/29/2022
• Supplement Dates FDA Received: 11/18/2022; 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2010
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male