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

Model Number NOT PROVIDED

Device Problem Mechanical Problem (1384)

Patient Problem Toxicity (2333)

Event Date 07/07/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information, including device details, post primary and pre revision x-rays, operative notes and the return of the explanted devices has been requested in order to progress with this investigation, and if received, will be provided in a supplemental report upon completion of the investigation.Upon receipt of the appropriate device details, the relevant device manufacturing records will be identified and reviewed.

Event Description

Cormet revision after approximately 10 years due to reported grinding and elevated cobalt and chromium levels.

Manufacturer Narrative

(b)(4) final report.In order to conduct a thorough investigation of the event, additional information was requested.As the device details were not provided, the manufacturing records were not retrieved.The explants were not returned and the patient medical history was not provided, therefore we were unable to determine the root cause of the event.Without more information, no further investigation could be performed and thus corin considers the case closed.However, should any additional information become available for this event, this case may be re-opened for further investigation.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 approximately 10 years due to reported grinding and elevated cobalt and chromium levels.

• Brand Name: CORMET
• Type of Device: RESURFACING HIP PROSTHESIS
• Manufacturer (Section D): CORIN MEDICAL; the corinium center; cirencester, GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 7281172
• MDR Text Key: 100414550
• Report Number: 9614209-2018-00013
• 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: 03/25/2020

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 Model Number: NOT PROVIDED
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/23/2018
• Initial Date FDA Received: 02/19/2018
• Supplement Dates Manufacturer Received: 01/23/2018
• Supplement Dates FDA Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR