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

Model Number 570-06-056

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 01/27/2021

Event Type  Injury  

Manufacturer Narrative

Per (b)(4)- initial report.Additional information, including post primary and pre revision x-rays, operative notes, patient age and activity level, patient medical history, a recent update on the patient and the reference and lots of the devices 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 requested and if provided, the relevant device manufacturing records will be identified and reviewed.

Event Description

Cormet revision after approximatively 11 years due to pain and infection.

Event Description

Cormet revision after approximatively 11 years due to pain and infection.

Manufacturer Narrative

(b)(4) - final report.Additional information, including post primary and pre revision x-rays, operative notes, patient age and activity level, patient medical history, a recent update on the patient and the reference and lots of the devices has been requested in order to progress with the investigation of this event.Partial information was provdided.The appropriate device details were provided, and the relevant device manufacturing records have been identified and reviewed.All parts associated with these records were manufactured, packaged, and sterilised to the correct specifications at the time of manufacture.The patient medical records were provided.It confirmed the patient statement to the reporter about the revision.Infections are generally linked to patient characteristics, length of surgical procedure, length of hospital stay, and factors related to the operative environment (including the number of personnel in the operating room and potential contamination of equipment or instrumentation).All invasive procedures involve contact by a medical device or surgical instrument with a patient's sterile tissue or mucous membranes.A major risk of all such procedures is the introduction of pathogens that can lead to infection.Failure to properly disinfect or sterilize equipment carries not only the risk associated with breach of host barriers but also a risk for person-to-person transmission and transmission of environmental pathogens.The cleaning method, the sterilization method and sterile barrier system used to package cormet devices has a long history of safe and effective use at corin for a wide range of orthopedic devices and has been validated in accordance with the relevant standards.Infection is a known complication with any invasive surgery procedure and the incident rate is followed by performing trending on reported events.Based on the above, no further investigation can be conducted, and the root cause of the reported infection could not be determined.The submission of this report does not constitute and admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.

• Brand Name: CORMET
• Type of Device: HIP RESURFACING SYSTEM
• Manufacturer (Section D): CORIN MEDICAL; the corinium center; cirencester, GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN MEDICAL; the corinium center; cirencester, GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: dardam uka ; the corinium center; cirencester, GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 12605508
• MDR Text Key: 275867688
• Report Number: 9614209-2021-00119
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 08/01/2012
• Device Model Number: 570-06-056
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: LGMB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CORMET HEAD: PART NO. 571-06-048 LOT LHNB
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Race: White