MAUDE Adverse Event Report: CORIN MEDICAL CORMET; HIP RESURFACING SYSTEM

Model Number 179.640

Device Problems Inadequacy of Device Shape and/or Size (1583); Use of Device Problem (1670)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed for the cormet head.All parts associated with these records conformed to dimensional specifications, and were labeled as size 40mm.A pre-revision x ray was provided and will be reviewed.Conclusions will be provided in a supplemental report.A post-revision xray and operative notes were requested but were not available.The revision was reported to be completed successfully.The patient fells well.The activity level of the patient was reported to be high.The explanted devices will be returned to corin and will be reviewed.Conclusions will be provided in a supplemental report.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.

Event Description

Cormet revision after approximately 11 years and 7 months due to incorrect size cormet head being implanted into the patient: a cup size 50mm was implanted with a head size 40mm (instead of 44mm).

Manufacturer Narrative

Per 3319 - final report the appropriate device details were provided and the relevant device manufacturing records has been identified and reviewed.All finished parts associated with these records conformed to material and dimensional specifications at the time of manufacture.As a result of investigation for removed implants, they are cormet products and the size of the cup (50mm) and the head (40mm) did not match.Originally, 44mm head should have been used for 50mm cup.It is confirmed that the size 2 head was the inappropriate size.The inappropriate cormet head size was implanted related to an external root cause.Based on this, corin now considers this case closed.Please note: this report is filled 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

Cormet revision after approximatively 11 years and 7 months due to incorrect size cormet head being implanted into the patient: a cup size 50mm was implanted with a head size 40mm (instead of 44mm).

• Brand Name: CORMET
• Type of Device: HIP RESURFACING SYSTEM
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 10903823
• MDR Text Key: 218234323
• Report Number: 9614209-2020-00112
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P050016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2013
• Device Model Number: 179.640
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 110754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2020
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORMET CUP: PART NUMBER 179260C, LOT 081615; CORMET CUP: PART NUMBER J179.250C LOT 081615; STEM: PART UNKNOWN LOT UNKNOWN; STEM: PART UNKNOWN, LOT UNKOWN; CORMET CUP: PART NUMBER 179260C, LOT 081615; STEM: PART UNKNOWN, LOT UNKOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR