MAUDE Adverse Event Report: CORIN MEDICAL BIPOLAR; CORIN BIPOLAR PROSTHESIS

Model Number J111.252

Device Problem Device Slipped (1584)

Patient Problem Failure of Implant (1924)

Event Date 09/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).No adverse event has been reported.The event reported to corin, that "the head of a pre assembled bipolar prosthesis came out" is identifiable and an alternative device could be used.However, the event report submitted to corin also mentions a device revision, it is unknown at this time whether or not the devices being revised were corin products.This information has been requested, and if received, will be provided in a supplemental report upon completion of this investigation.The appropriate device details have been provided and the relevant device manufacturing records have been identified and reviewed, this device conformed to material and dimensional specification at the time of manufacture.Please note: this report is filed with the fda due to an 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

The head came away from a pre assembled corin bipolar prosthesis.

• Brand Name: BIPOLAR
• Type of Device: CORIN BIPOLAR PROSTHESIS
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: lucinda gerber ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ ; 1285659866
• MDR Report Key: 7017848
• MDR Text Key: 91760875
• Report Number: 9614209-2017-00073
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K925897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: J111.252
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 344547
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1