MAUDE Adverse Event Report: CORIN MEDICAL BIPOLAR; BIPOLAR PROSTHESIS

Model Number J111.243

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 10/08/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Additional information, including confirmation on which devices were revised, part nos.And lot codes of all devices that the patient had implanted prior to the revision, post primary and pre revision x-rays, operative notes (primary and revision(s)), patient age, activity level, medical history and weight and the return of the explanted 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 provided and the relevant device manufacturing records will be identified and reviewed.Please 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.

Event Description

The patient dislocated when getting out of bed.The surgeon tried to relocate the leg and when he pulled it the head pulled out of the insert and thus a revision was required.

Event Description

The patient dislocated when getting out of bed.The surgeon tried to relocate the leg and when he pulled it the head pulled out of the insert and thus a revision was required.

Manufacturer Narrative

(b)(4) - final report.The reported devices were not returned to corin uk.The operative notes were not provided.The investigation is based on the review of x-rays of the primary surgery of the first revision as the ones of the second revision were not available.The relevant device manufacturing record has been identified and reviewed.This device was manufactured in april 2020, all parts associated with this record conformed to material and dimensional specification at the time of manufacture.The patient was reported to be a female, having dementia.The reporter informed us that the patient fell out of bed.The fall from her bed was the main contributor to the dislocation and not a failure of the device.Based on this, this case is now considered closed.Please 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 enttiy, entity's representative or distributor caused or contributed to this event.The device details provided initially were inaccurate.The appropriate device details were finally provided and corrected in this report.It was found that this part is not commercialized on the us market.

• Brand Name: BIPOLAR
• Type of Device: 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: marie anne euzen ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 12697321
• MDR Text Key: 278535560
• Report Number: 9614209-2021-00126
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: J111.243
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 453671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2020
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female