MAUDE Adverse Event Report: CORIN LTD (UK & FR) OPTIMUM MODULAR HEAD; OPTIMUM HEAD (12/14)

Model Number E079.744

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 11/09/2022

Event Type  Injury  

Event Description

Right side revision hip surgery due to unknown reasons.Competitor stem, optimom head and competitor liner removed and replaced with smith & nephew stem, smith & nephew head and mobilt liner.Cormet cup remains in-situ.Patient is a 64 y/o female with unknown activity levels and weight.Implants involved: optimom eurocone modular head short 44mm (explanted); part # e079.744; lot # jvhv.Cormet cup pegless bicoated 50mm (in-situ); part # 179.250b; lot # kfrz.

Manufacturer Narrative

(b)(4) initial report additional information was requested, such as the reason for the revision, xrays, operative notes, patient age, activity level, weight and medical history, and an update on the patient post-revision.Additional information will be reviewed and additional information will be provided in a supplemental report.The device details were provided.The manufacturing records will be located and review.Conclusions will be provided in a supplemental report.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.

• Brand Name: OPTIMUM MODULAR HEAD
• Type of Device: OPTIMUM HEAD (12/14)
• Manufacturer (Section D): CORIN LTD (UK & FR); the corinium centre; cirencester ; UK
• Manufacturer (Section G): CORIN LTD (UK & FR); the corinium centre; GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: dardan uka ; the corinium center; UK GL7 1YJ
• MDR Report Key: 15868330
• MDR Text Key: 304331410
• Report Number: 9614209-2022-00125
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K111911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2011
• Device Model Number: E079.744
• Device Lot Number: JVHV
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/09/2022
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2006
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CORMET CUP 179.250B LOT KFRZ.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female