MAUDE Adverse Event Report: CORIN LTD (UK & FR) MOBILIT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 09/11/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Part number, lot code, date of revision, operative note, information on the tube and the surgical technique have been requested in order to progress with the investigation of this event.The relevant device manufacturing record will be identified and reviewed when the lot code will be communicated.Information will then be provided in a supplemental report upon completion of the investigation.Please note: 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.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

Surgical intervention on mobilit 2 days after implantation due to the drain tube entrapped between the articulating surfaces of the cup.

Manufacturer Narrative

(b)(4) final report.Additional information, including part number and lot code of the cup, date of revision and operative notes was requested in order to progress with the investigation of this event, however, this information could not be provided.The appropriate device details were not provided, thus the relevant manufacturing record was not identified and reviewed.No data could be found in literature regarding the incidence of vacuum drainage tube entrapment following total hip arthroplasty.This must have occurred either during the transfer of the patient from the operating table or during the immediate postoperative period.Based on this, no further investigation can be conducted, and the root cause could not be identified.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 occured outside of the usa.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.

• Brand Name: MOBILIT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): CORIN LTD (UK & FR); the corinium centre; cirencester GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN LTD (UK & FR); the corinium center; cirencester GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: dardan uka ; the corinium center; cirencester GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 17772776
• MDR Text Key: 323713647
• Report Number: 9614209-2023-00235
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K191831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/11/2023
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 09/11/2023
• Supplement Dates FDA Received: 12/07/2023
• 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
• Treatment: MEIJE DUO STEM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female