MAUDE Adverse Event Report: CORENTEC CO., LTD. MIRABO CUP ; PROSTHESIS, HIP SEMI - CONSTRAINED METAL / POLYMER, CEMENTED OR UNCEMENTED

Model Number H1.A11.1058

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Toxicity (2333)

Event Date 10/06/2016

Event Type  Injury  

Event Description

Experienced problems after a left hip replacement using a corentec set of components.The surgery was done by a (b)(6).Developed high level of cobalt metal ion poisoning that required the hip to be explanted and replaced in (b)(6) 2019.Corentec components used in the explanted hip were - 36mm mrabo pe liner (h1.L61.3648), mirabo cup (h1.A11.1058), metal head (01.02.452), m stem (ha.F22.1007).(b)(4).

• Brand Name: MIRABO CUP
• Type of Device: PROSTHESIS, HIP SEMI - CONSTRAINED METAL / POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): CORENTEC CO., LTD.
• MDR Report Key: 9008489
• MDR Text Key: 158638050
• Report Number: MW5089740
• Device Sequence Number: 3
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/09/2019
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: H1.A11.1058
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 60 YR
• Patient Weight: 107