MAUDE Adverse Event Report: CORIN MEDICAL TRINITY; ACETABULAR HIP SYSTEM

Model Number 321.04.356

Device Problems Device Dislodged or Dislocated (2923); Output Problem (3005)

Patient Problem No Code Available (3191)

Event Date 09/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Additional information including post primary and pre revision x-rays, operative notes, patient age and activity level, patient medical history 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.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

Trinity revision after approximately 2 months due to mal-orientation of the cup resulting in impingement and dislocation.

Manufacturer Narrative

Per -1471 final report additional information including post primary and pre revision x-rays, operative notes, patient details and the return of the explanted devices was requested in order to progress with the investigation, however, not all information was available and the explants could not be returned.The appropriate device details were provided and the relevant device manufacturing records were identified and reviewed.All parts associated with these records conformed to material and dimensional specification at the time of manufacture.It was reported to corin that the impingement and dislocation was a result of malorientation of the cup and thus corin now consider this case closed, however, should any additional information be provided then this case may be re-opened for further investigation.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 entity, entity's representative or distributor caused or contribited to this event.

Event Description

Trinity revision after approximately due to maleorientation of the cup and resulting impingement and dislocation.

• Brand Name: TRINITY
• Type of Device: ACETABULAR HIP SYSTEM
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 7872669
• MDR Text Key: 120129328
• Report Number: 9614209-2018-00070
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K093472
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/06/2019

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 Expiration Date: 04/18/2023
• Device Model Number: 321.04.356
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 383144
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2018
• Initial Date FDA Received: 09/13/2018
• Supplement Dates Manufacturer Received: 09/10/2018
• Supplement Dates FDA Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIOLOX CERAMIC HEAD - 104.3610, 396753; BIOLOX CERAMIC HEAD - 104.3610, 396753; METAFIX STEM - 579.1007, 371571; METAFIX STEM - 579.1007, 371571; TRINITY ECIMA LINER - 322.04.636, 386929; TRINITY ECIMA LINER - 322.04.636, 386929; BIOLOX CERAMIC HEAD - 104.3610, 396753; METAFIX STEM - 579.1007, 371571; TRINITY ECIMA LINER - 322.04.636, 386929
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR